Iso 13485 Iso 9001

广州市丰华生物工程有限公司
Guangzhou Fenghua Bioengineering Co.,Ltd.

Co Ltd
新型冠状病毒（SARS-CoV-2）IgM/IgG联合
新型冠状病毒（SARS CoV 2）IgM/IgG联合
快速检测试剂盒资质文件
Qualification Documents of SARS-CoV-2
IgM/IgG Combo Rapid Test Kit
ISO 13485
ISO 9001
目录/Catalogue
Ⅰ产品介绍Product Introduction
1.1 产品彩页Product Brochure···················1
1.2 使用指南 Instruction for Use··················3
1.3 包装规格 Package Scheme······················5
1.4 产品说明书Kit Inserts···························9
Ⅱ产品资质Product Qualification
2.1 医保商会白名单Free Sale Certificate················11
2.2 CE-IVD 证书CE-IVD Certificate··············14
2.3 美国 FDA 紧急使用（EUA）证明FDA EUA Certification····18
2.4 广东省医疗器械质量监督检验所出具的检验报告Clinical
VerificationReport Issued by Guangdong Medical Devices
Quality Surveillance and Test Institute·················22
2.5 货物运输条件鉴定书Certification for Transport of
Goods·································50
SARS-CoV-2 IgM/IgG Combo Rapid Test Kit
(Whole Blood/Serum/Plasma)
Rapid results in 15 min.

Test both IgM and IgG antibodies.
Easy to use with no analyzer required.
Store at room temperature or refrigerator.
Whole blood (finger prick available), serum and plasma sample.
1
IVD products
CORONA VIRUS
Easy to use/Fast detection/No equipment
HOW IT WORKS*
IgM and IgG antibodies to a coronavirus (SARS-CoV-2) protein are detected qualitatively using whole
blood, serum, or plasma. This point-of-care device works similarly to the home pregnancy test.
1 2 4
3
* Refer to the instruction manual for further details.
Q&A
Q: What is the kit used for?
A: The kit is suitable for rapid, qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-
CoV-2) IgM /IgG antibodies in human serum, plasma, or whole blood.
Q: Should I use the kit?
A: Since the patient may not know if they are infected, it's necessary for testing both IgM and IgG.
Q: What is the kits’ limit of detection?
A: Because antibodies are vary based on different conditions, limit of detection will be different for each person.
Q: Can you meet my demand?
A: Yes, we can scale our production to meet your needs. Our ordinary turnaround time is 1 week.
Order
Cat No. Description Package Store Temo.
COV2 SARS-CoV-2 IgM/IgG Combo Rapid Test Kit 1T/box, 20T/box, 50T/box, 100T/box 2-30 ℃
Guangzhou Fenghua Bioengineering Co.,Ltd. No. 6 Yinyi Street , Guangzhou

Economic and Technological Development District, Guangdong, P. R. China
T: +8620-82099258/F: +8620-82099456/michaelzg00@163.com/www.bio-fenghua.com
2
SARS-CoV-2
Instruction for Use
1 2
Disinfect the blood collection area with Absorb peripheral blood (about 20 ul)
75% alcohol and cotton buds. When with the pipette, and add one drop of
dry, puncture fingertip using a blood into each sampling well (S well)
disposable lancet. of test card.
3 4
Add 2 drops sample dilution solution Wait for about five minutes, then read
into each sampling well (S well) of test the results. The results over 15
card. minutes are invalid.
* Refer to the instruction manual for further details. Serum and plasma can also be used.

T: +8620-82099258/F: +8620-82099456
E:michaelzg00@163.com/W:www.bio-fenghua.com
3
SARS-CoV-2
Result Interpretation

T: +8620-82099258/F: +8620-82099456
E:michaelzg00@163.com/W:www.bio-fenghua.com
4
Guangzhou Fenghua Bioengineering Co., Ltd.
Package Scheme
Updated on June 22th
1. Package of 50 Tests/Box
Box size: 250mm*165mm*70mm;
Box weight: 642g;
A box has:
 50×Test Cassette;
 1×Sample diluents(12ml);
 50×Pipettes;
 1×IFU Leaflet.
Carton size: 635mm*490mm*358mm;
Carton weight: 13.0 kg;
A Carton has:
 18×Boxes(i.e.900Tests)
Web: www.bio‐fenghua.com
5
2. Package of 50 Tests/Box（Option 2）
Box weight: 860g;
A box has:
 50×Sample diluents(0.5ml);
 50×Pipettes;
 1×IFU Leaflet.
A Carton has:
6
3. Package of 20 Tests/Box
Box weight: 300g;
A box has:
 1×Sample diluents(5ml);
 20×Pipettes;
 1×IFU Leaflet.
A Carton has:
7

4. Package of 1 Test/Box
Box weight: 31.60g;
A box has:
 1×Sample diluents(0.5ml);
 1×Pipettes;
 1×Disposable lancet;
 1×Alcohol Prep Pads;
 1×IFU Leaflet.
A Carton has:
 312×Boxes(i.e. 312Tests)
8

CoV-2 IgG is on the right. There is no interference between the two minutes has elapsed may be inaccurate.
tests because the test membranes are separated. [Result Interpretation]
Other Material Required But Not Provided 1. Positive Results:
SARS-CoV-2 IgM/IgG Combo 1. Specimen collection containers. Observe the two colored lines in the control (C) in control regions, and
Rapid Test Kit 2. Centrifuge (for serum/plasma sample). the test line in the IgM/IgG test (T) region of the cassette.
3. Timer. a) In addition to the presence of both control lines (C), if only the IgM
For in vitro diagnostic use only.
4. Personal protective equipment, such a protective gloves, medical mask, test line (T) appears, the test result indicates the presence of the
goggles and lab coats. SARS-CoV-2 IgM antibodies.
[Product Name] 5. Appropriate biohazard waste container and disinfectants. b) In addition to the presence of both control lines (C), if only the IgG
SARS-CoV-2 IgM/IgG Combo Rapid Test Kit [Storage and Stability] test line (T) appears, the test result indicates the presence of the
SARS-CoV-2 IgG antibodies.
[Available Product Size] 1. Store at 2~30ºC in the sealed pouch up to the expiration date printed on
the package. Do not freeze. c) In addition to the presence of
1 test/box, 20 tests/box, 50 tests/box and 100 tests/box. both control lines (C), if both
2. The test cassette should be used within 1 hour after taking out from the
[Intended Use] foil envelope. Sample diluents should be re-capped in time after use. IgM and IgG test lines (T)
3. Keep away from sunlight, moisture and heat. appear, the test result indicates
This kit is suitable for rapid, qualitative detection of COVID-19
4. Kit contents are stable until the expiration date printed on the outer the presence of the
（SARS-CoV–2）IgM/IgG antibodies in human serum, plasma, or whole
box. SARS-CoV-2 IgM and IgG
blood.
5. The manufacture date and expiry date can be found on the label of the antibodies.
[Principle] Note:The intensity of the color in the test line (T) region may vary. If there
kit.
This kit is based on the principle of colloidal gold is only a faint line (weak positive) in the IgM antibody testline (T)
[Sample Collection and Preparation]
immunochromatography for detection of SARS-CoV-2 IgM/IgG area, it is recommended to repeat the dual test. When two of the
antibodies in human serum, plasma, or whole blood. The colloidal Serum, plasma, or whole blood should be collected in accordance with the three tests shows a faint line (weak positive) in the test line (T)
gold-labeled mouse anti-human IgM or IgG monoclonal antibodies will local guidelines and procedures without hemolysis. When handling area, which is interpreted as positive results.
form the immune complexes with the SARS-CoV-2 antibodies in the specimens, disposable straws and pipette tips are required, and caution
2. Negative Results:
human specimen, thus react with the SARS-CoV-2 antigen, and develop must be taken to prevent cross-contamination. Serum or plasma samples
If control lines (C) are present in both result windows and
red colored bands at the test lines (T). should be shipped at low temperature. They can be stored at 2~8 ºC for
no test lines (T) appear in either IgG or IgM test line
seven days, and at -20 ºC for long-term storage. Avoid repeated freezing
[Material Provided] regions, the test result is negative for both antibodies.
and thawing.
Reagents and Materials Provided Note:Allow specimens to room temperature before testing. Frozen
The kit components for 4 different kit sizes: specimens should be completely thawed and mixed well before
Kit Size (#of Tests) 1 20 50 100 testing. Specimens should not be frozen and thawed repeatedly. 3. Invalid Results:
Test Cassette(#) 1 20 50 100 Severe hemolytic or heat-inactivated specimens are not If control lines (C) do NOT appear, the test result is invalid regardless of
Sample Diluents 5.0 ml×1 14.0 ml×1 28.0 ml×1 recommended. the appearance of the IgM or IgG test lines (T).
0.5ml
(# of Bottles) or or or Some causes of invalid results are: not following the directions correctly
×1 [Test Procedures]
0.5ml×20 0.5ml×50 0.5ml×100 or the test may have deteriorated beyond the expiration date. It is
Components
Read the instructions carefully before use. Allow the test card, sample recommended that
Pipette(#) 1 20 50 100
dilution solution and specimen to room temperature before testing. the sample be
IFU Leaflet 1 1 1 1
1. Sample preparation: re-tested using a new
Disposable
1 No No No a) Serum/plasma: Add 10l each of the test sample to both sample cassette.
Lancet(#)
wells of the cassette, then add 100l (about two drops) sample
Alcohol Prep
1 No No No dilution buffer to both sample wells.
Pads(#)
b) Whole blood or peripheral blood samples: Add 20l each of the test
Test cassettes are individually sealed in the aluminum foiled pouch with a
sample to both sample wells of the cassette, then add 100l (about
desiccant. Each test cassette includes two test regions (SARS-CoV-2 IgM 4.Interpretation antibody tests with nucleic acid test
two drops) sample dilution buffer to both sampling wells.
and SARS-CoV-2 IgG). (NAT) results together (Reference 2):
2. Interpretation of results: Please interpret the results within 5~15
a) Patients with a positive NAT result, then the results as follows:
Note: The test of SARS-CoV-2 IgM is on the left, and the test of SARS- minutes. Invalid data: reading the results before 5 minutes or after 15 9

 IgM(+) and IgG(+):The patient in the active phase of infection, and detection limit of the assay, or if the virus has undergone minor amino necessary protection, wash your hands afterwards.
developed immunity to the SARS-CoV-2 (long-term persistent acid mutation(s) in the epitome recognized by the antibody used in the 7. This test cassette is for one-time use. After use, the test cassette and
antibody IgG has been produced). test. samples should be considered as medical waste with biological
 IgM(+) and IgG(-):The patient may be in the early stage of a 4. The test is limited to the qualitative detection of antibodies specific for infection risk and should be properly disposed according to the
SARS-CoV-2 infection, the immune system produces the early the SARS-CoV-2 virus. The intensity of the test line does not relevant national regulations.
antibody IgM, but has not yet produced IgG, or the IgG has not yet necessarily correlate to SARS-CoV-2 antibody titer in the specimen. 8. This kit should be used by professionally trained
reached the detection limit. 5. China National Medical Products Administration (NMPA) recommend personnel. Thoroughly understanding of this manual and strict
 IgM(-) and IgG(+):The patient may be in the late stage of a that the antibody detection only used as a supplementary test for operation is important. Any operation that contradicts the instructions
SARS-CoV-2 infection, or a recurrent infection. suspected cases with negative nucleic acid detection of the corona will lead to inaccurate results.
 IgM(-) and IgG(-):Patients may be in a "window period" of virus, or used in conjunction with nucleic acid detection in the 9. A clean laboratory environment is critical for using this kit and reliable
SARS-CoV-2 infection, a period between infection and the point diagnosis of suspected cases, and is not used as a basis for the interpretation.
when the test will give an accurate result. diagnosis and elimination of new corona virus infection. Not suitable 10. If there is any concern about the results, repeating the test is
b) Patients with a negative NAT result, then the results as follows: for general population screening for novel corona virus infections, too. recommended.
 IgM(+) and IgG(+):The patient has recently been infected with a 6. Please use this kit in accordance with local regulations and 11. Consider any materials of human origin as infectious, handle with
SARS-CoV-2 and is in the recovery phase. The virus has been implementation guidelines. standard biosafety procedures.
cleared from the body and the IgM has not been reduced to the [Performance Characteristics]
lower limit of detection; or the nucleic acid test result is false 1. Detection limit: ≥ 1:16 testing with the standard control reference [Index of Symbol]
negative and the patient is in an active infection period. samples.
 IgM(+) and IgG(-):Positive IgM indicates that it is likely to be in the 2. Detection rate of negative samples: 100% using the standard control
acute phase of the SARS-CoV-2 infection. At this time, it is negative reference samples.
necessary to consider the doubtful nucleic acid test results and need 3. Detection rate of positive samples: 100% using the standard control
to repeat sampling; or IgM false positives caused by the patient's negative reference samples.
own rheumatoid factor positive, etc., need to be further reviewed 4. Reproducibility: The consistency rate of testing the negative and
after 1 week period. positive reference samples at all magnitude levels is no less than 95%.
 IgM(+/-) and IgG(-):Suggest the patient was infected with the 5. Batch variation: Use three different batches of kits to test the negative,
SARS-CoV-2, but with very low viral load at an early stage. The weakly positive and positive reference samples ten times. The
viral load is lower than the detection limit of nucleic acid test. The consistency rate of negative and positive controls at all levels is at
immune system produces small amount of IgM, and has not yet least 95%.
produced IgG; or IgM false positive caused by the patient's own 6. High-dosage hook effect: No false negative results when testing with
rheumatoid factor, etc. Suggest to be retested after 1 week. high concentration of standard positive reference samples three times.
 IgM(-) and IgG(+):Suggest the patient may have been infected with [Precautions]
the SARS-CoV-2, but the virus has been cleared by the body; and

1. This product is for in vitro diagnostic use only. Operations should be Guangzhou Fenghua Bioengineering Co., Ltd.
the IgG produced by the immune system is maintained in the body,
carried out in strict accordance with the instructions. Do not use No. 6 Yinyi Street , Guangzhou Economic and
and is still present in the blood to be detected for a long period. Technological Development District, Guangdong, P. R.
expired or damaged products. China 510730
 IgM(-) and IgG(-): Healthy people or incubation period of infection.
2. Only use the test cassette with sample diluents provided in the same Tel: +8620-82099258 Fax: +8620-82099456
[Limitations of Procedure] Web: www.bio-fenghua.com
package. Samples diluents from different batches should not be mixed.
1. The accuracy of the test depends on the sample collection process. 3. Do not use tap water, purified water, or distilled water as sample
Valid from June 3, 2020
Improper sample collection, improper sample storage, or repeated diluents or negative controls.
freezing and thawing of the sample will affect the test result. 4. The test cassette should be used within 1 hour after opening. If the
2. The test results of this product are for clinical reference only and ambient temperature is higher than 30 ℃ or humid, it should be used
should not be used as the sole basis for clinical diagnosis and treatment. immediately.
The clinical management of patients should be considered in 5. If no liquid migration occurs in the test window within 30 seconds
combination with their symptoms, medical history, other laboratory after adding sample diluents buffer, add another drop of sample
tests, treatment response, and epidemiology. diluents buffer.
3. A negative or non-reactive result can occur if the quantity of antibodies 6. Protect yourself from any potential virus infection when collecting
for the SARS-CoV-2 virus present in the specimen is below the specimens. Please wear disposable gloves, masks, and all other 10
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（生服。
CERTIFICATE OF NOTIFICATION
η1is is to ce目. 的that, according to the council directive 98/79/EC, SUNGO per岛nned all
notification duties and responsibilities出出e European authorized representative of:
An
＆，‘
－
d俨命
m
Guangzhou Fenghua Bioengineering Co吁Ltd.

四川队
i
h
u
z AU
A
No.6 Yinyi Street, Guangzhou Economic and Technological

副
M
Development Dis位ict, Guangdong, P. R. China

The Manufacturer has provided SUNGO with all the appropriate declarations according to the
98/79厄C Directive requirements including the EC Declaration of Confonnity confirming that his In
vitro diagnostic medical device, as stipulated here below, is fulfilling the applicable requirements of
the European Council Directive 98/79/EC.
Product(s): SARS-Co -2 IgM/IgG Combo Rapid Test Kit

Type(s): 1 test/box, 20 tests/ho元50 tests/box and 100 tests/box.
Product Cl部 sification: IVDD Other
Where the manufacturer affix’s the CE marking to the product listed they must ensure that all the
requirements of the appropriate EU directive(s) have and continue to be met.
The notification of a岛rementioned device has been completed by the European Representative in
Netherlands. The Netherlands Competent Authority is notified of the manufacturer's medical
devices and has allocated registration. NOTIS number is CIDG-20200815.
4φd石〈 Issued: Ap 民 02 2020

Cert. N 。.： EU309518
Executive Director Expiration Date: Apι012025
This is not a CE mark and is only

provided as a template for
Informational purpose.
14
15
16
17
18
19
20
FDA：
已经完成注册，在等FDA分配注册号码，按照美国规定，等待时间为
90天或者更长才能给到FDA注册号，现在已经可以在网站上查询到丰
华的信息：
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
通过 Owner/operator number: 10071704, 可以查询到丰华的信息如下：
21
SINCE 1988
检验报
左仨
口
报告编号 MZ20140112
委托方广州市丰华生物工程有限公司
样品名称新型冠状病毒 (2019-nCoV) IgM/ IgG 抗体联合检
测试剂盒(胶体金法)
型号规格 10 人份/盒
检验类别注册检验 ( .j )
注册补充检验( )
其他检验( )
广东省医如器械质量监督检验所
国家食品药品监督管理局广州医疗糠械质量监督检验中心
22
注意事项
一、本报告未加盖本检测机构检验报告专用章无效。
二、未经本检测机构批准，不得部分复制本报告。
三、本报告无批准人签字无效。
四、本报告涂改无效。
五、对本报告若有异议，应于收到报告之日起七个工作日内以书面方
式向检验单位提出，逾期不予受理。
六、本报告仅对来样负责。
地址:广州市黄埔区科学城光谱西路 1 号
咨询电话 020-66602388 (日常检验)、 020-66602531 (监督抽验)
传真 020-66602400 (日常检验)、 020-66602534 (监督抽验)
邮政编码 510663
网站 www. gdmd t. org. cn
邮箱 gdmitc-ywbIDgdda. gov. cn
23
广东省医疗器械质量监督检验所
国家食品药品监督管理局广州|医疗器械质量监督检验中心
检验报告首页
报告编号 MZ20140 1l 2 共 11 页第 1 页
新型冠状病毒 (2019-nCoV) IgMlIgG 抗

样品名称体联合检测试剂盒(肢体金法) 样品编号 MZ20140112
送样 (j) | 抽样(们
商标 / 型号规格 10 人份/盒
委托方广州市丰华生物工程有限公司检验类别注册检验
委托方地产品编号
广州经济技术开发区银谊街 6 号 20200204 、 20200205 、 20200206
址 / 批号
抽样单编
生产单位广州市丰华生物工程有限公司
号
2020/02/04 、 2020/02/05 .
受检单位广州市丰华生物工程有限公司生产日期
2020/02/06
抽样单位广州市市场监督管理局样品数量各 16 盒
广州市丰华生物工程有限公司成品仓冷
抽样地点抽样基数
库
抽样臼期 2020 年 02 月 13 日检验地点中山检验室

收样日期 2020 年 02 月 20 日检验臼期 2020.02.20~2020.03.02
检验项目全项目
广州市丰华生物工程有限公司发布的《新型冠状病毒( 20 19-nCoV ) 19M/lgG 抗体联合检

检验依据
测试剂盒(肢体企法)))产品技术要求
被检样品符合广州市丰华生物工程有限公司发布的《新型冠状病毒 (2019-nCoV)
IgMlIgG 抗体联合检测试剂盒(肢体金法)))产品技术要求。
结论:合格.
,. \, 47字
f.f;.ri-- 飞、
检验结论
( 检验报告专用章或检验单位公章)
签发日期: ~02.o..:年 03月 05 日

J
总川
1)报告中的"一表示此项不适用，报告中 "j"表示此喷空白 J ‘ \ "'，: "1.. ~..~.\
备 2) 参考品信息见报告第 2 页附表 1 和报告第 3 页附表 2 ，参考品补充说明瓜报告第 3 页.
注
3 )对广州市丰华生物工程有限公司发布的《新型冠状病毒 D01 9-neoV ) JgMlIgG 抗体
。一(阳城…
多7吵吵、品加一带着是
4 担~
职务 : 授权签字人
24
国家食品药品监督管理局广州医疗器械质量监督检验中心
检验报告
报告编号 MZ20140112 样品编号 MZ20140112 共 11 页第 2 页
附表 1 参考品信息表- '1 11 M 企业参考品

序号名称组成编号浓度或其他描述批号来源样本类型说咽
L1- L6的稀释度为抗 20 19-nCoV IgM强阳(稀释比 1:32 ) 用不同浓度梯度( 1:1-
广东省
检出限参性样本用样本稀释液按试1Ì'J 金说明书进行 1:10 稀释后，然 1:32) 的检出限参考品直
l 6份 Ll -L6 20200203 第二人血清
考品后再用样本稀释液按 1:1 ， 1:2 ， 1:4， 1:8 ， 1:16 ， 1:32 稀释比例进行接测试，各浓度检测 1 次，
民医院
稀释的. 检出限 >1:16_
含嗜肺军团菌 l 份{编号 QI) 、肺炎支原体 2 份(编号 Q2_
Q川、 Q 热立克次体 l 份{编号 Q4)、肺炎衣原体 3 份(编
号 Q5 、 Q6 、 Q7)、腺病毒 2 份(编号 Q8 、 Q川、呼吸道合广东省
阴性参考检测 20 份阴性参考品各
2 20 份 Q1 -Q20 胞病毒 1 份(编号 QIO)、甲型流感病毒 2 例(编号 Qll 、 20200203 第二人血清
口口口 1 次，结果应均为阴性.
Q12) 、乙型流感病毒 2 例(编号 Q13 、 Q14) 、副流感病毒民医院
例 2 例(编号 QI5 、 Q16)、风莎病毒 2 例(编号 Q17 、 Q18)、
鼻病毒 2 例(编号 QI9 、 Q20).
①抗 2019-nCo V IgM 阳性样本，其中 P1 为强阳性(稀释广东省
阳性参考检测 5 份阳性参考品检
3 5 份 PI 町 P5 比 1:16 );②P2 、 P3 为中阳性(稀释比 1:8 );③ P4 、 P5 20200203 第二人血清
品测.结果应均为阳性.
为弱阳性(稀释比 1:1 ). 民医院
①抗 2019-nCoV 19M阴性样本 l 份，为含嗜肺军团菌的交叉检测阴性、弱阳、阳性精
阴性 :QI 广东省
精密性参样本(编号 Q]}; ②抗 2019-nCoVIgM 弱阳性(稀释比 1:1) 密性参考品各 10 次，各
4 3 份弱阳 12 20200203 第二人血清
考品样本 1 份;③抗 2019-nCoVlgM 中阳性(稀释比七日)样本量级水平的阴阳性结果
阳性J3 民医院
1 份. 符合率均应不小于 95%.
高剂量钩广东省用高浓度的阳性参考品
5 状效应参 l 份 H 抗 20 19-nCoVIgM 强阳性(稀释比 1:64) 样本. 20200203 第二人血清检测 3 次，结果应不出现
考品民医院假阴性.
25
检验报告
附表 2 参考品信息表- I且G 企业参考品

序号名称组成编号浓度或其他描述批号来源样本类型说明
L!-L6的稀释度为抗 2019-llCoV IgG 强阳(稀释比 1 : 32 ) 用不同浓度梯度( 1:1-
广东省
检出限参性样本用样本稀释液按试剂金说明书进行 1 : 10 稀释后，然 1:32 )的检出限参考品直接
l 6 份 L! -L6 20200203 第二人血清
考品后再用样本稀释液按 1:1 ， 1:2.1 :4， 1:8.1:16.1 : 32 稀释比例进行测试，各浓度检测 l 次，
民医院
稀释的. 检出限问 :16.
含嗜肺军团菌 1 份(编号 QI ) 、肺炎支原体 2 份(编号 Q2 、
Q3)、 Q 热立克次体 l 份(编号 Q4)、肺炎衣原体 3 份(编
号 Q5. Q6 、 Q 7l、腺病毒 2 份{编号 Q8 、 Q9) 、呼吸道合广东省
阴性参考检测 20 份阴性参考品各 l
2 20 份 QI-Q20 胞病毒 l 份(编号 QIO)、甲型流感病毒 2 例(编号 Qll 、 20200203 第二人血清
n口n 次，结果应均为阴性 .
Q12) 、乙型流感病毒 2 例(编号 Q13 、 QI4). 副流感病毒民医院
例 2 例(编号 Q15 、 Q16)、风莎病毒 2 例{编号 QI7 、 Ql 川、
鼻病毒 2 例(编号 QI9 、 Q20).
①抗 2019-nCoVlgG 阳性样本，其中 PI 为强阳性{稀释比广东省

阳性参考检测 5 份阳性参考品检测.
3 5 份 PI-P5 1:16 );② P2 、的为中阳性(稀释比 1 : 8 );③ P4 、因为弱阳 20200203 第二人血清
品结果应均为阳性.
性(稀释比 1:1 ). 民医院
抗 20 I 9-nCoV IgG 阴性样本 l 份，为含嗜肺军团菌的交叉样检测阴性、弱阳、阳性精

阴性 : QI 广东省
精密性参本{编号 QI ); ②抗 2019-且CoVIgG 弱阳性(稀释比 1:1) 密性参考品各 10 次，各量
4 3 份弱阳: J2 20200203 第二人血清
考品样本 l 份;③抗 20 19-nCoVIgG 中阳性(稀释比 1:8 )样本 l 级水平的阴阳性结果符合
阳性 :13 民医院
份. 率均应不小于 95%.
高剂量钩广东省用高浓度的阳性参考品检
5 状效应参 l 份 H 抗 20 19-nCoVIgG 强阳性{稀释比 1 :64) 样本 20200203 第二人血清洲 3 次，结果应不出现假
考品民医院阴性 .
26
检验报告
对参考晶信息表的补充说明:
1 、参考品中的阳性样本按本司自研新型冠状病毒( 20 19-nCoV ) IgM/IgG 抗体联合检测试剂盒(肢体企法)
说明书进行操作检测为阳性，且再用样本稀释液按 1: ], 1: 2 , 1: 4 , 1: 8 , 1: 16 , 1: 32 , 1: 64 稀释
比例稀释后检测，大子等于 1: 16 稀释比例阳性的样本为强阳性;能达到 1: 2三稀释比例< 1: 16 阳性的
样本为中阳性;原倍5稀释比例< 1: 2 阳性的样本为弱阳性.
2 、检出限参考品已用样本稀释液预稀释，检测时直接使用，不需要再按说明说要求加入样本稀释液中混
匀后使用。除检出限参考品，其他参考品按说明书要求使用。
27
检验报告
报告编号 MZ20140 1l 2 样品编号 MZ20140 1l 2 共 11 页第 5 页
批号 20200204
序检验标准单项备
标准要求检验结果
号项目条款结论注
外包装完整无破损;标签清晰可辨;
外观 2.1 符合要求符合
液体试剂无杂质
IgM: 4 mm
2 膜条宽度 2.2 膜条宽度应不小于 3mm 符合
IgG: 4mm
IgM: 21 mmlmin
3 移行速度 2 .3 移行速度应不低于 10 mm/min 符合
IgG: 23 mmlmin
符合要求，检测 IgM 和 IgG 企业
用企业检出限参考品检测，检出限
4 检出限 2 .4 检出限参考品Ll ~L6 ，结果均为符合
主1:1 6
阳性，其中 L5 为 1: 16
阴性参考用企业阴性参考品检测，结果应均符合要求， lgM 和 IgG 企业阴性

5 2.5 符合
品符合率为阴性参考品 Q1~Q20 均为阴性
阳性参考用企业阳性参考品检测，结果应均符合要求， lgM 和 IgG 企业阳性

6 2.6 符合
品符合率为阳性参考结果均为阳性
企业弱阳性参考品 12 阳性结果
符合率 IgM 100% IgG 100%
检测企业阴性、弱阳、阳性精密性
企业阳性参考品 13 阳性结果符
7 重复性 2.7 参考品各 10 次，各量级水平的阴符合
合率 IgM100% IgG 100%
阳性结果符合率均应不小于 95%
企业阴性参考品 Q1 阴性结果符
合率 IgM 100% Ig Gl 00%
企业弱阳性参考品 J2 阳性结果
用 3 个不同批号的试剂(盒)分别符合率 IgM100% IgG100%
测试弱阳、阳性精密性参考品各 10 企业阳性参考品 13 阳性结果符
8 批问差 2.8 符合
次，各量级水平的阴阳性结果符合合率 IgM100% IgG100%
率均应不小于 95% 企业阴性参考品 Q1 阴性结果符
合率 IgM 100% IgGl 00%
检测 IgM 企业阳性参考品 H ， 3
高剂量钩用高浓度的企业阳性参考品检测 3 次结果均为阳性
9 2.9 符合
状效应次，结果应不出现假阴性检测 IgG 企业阳性参考品 H ， 3
次结果均为阳性
28
检验报告
批号 20200205
亏
口项目条款结论注
IgM: 4 mm
IgG: 4mm
IgM: 25 mmlmin
3 移行速度 2.3 移行速度应不低于 10 mm/min 符合
IgG: 21 mmlmin
4 检出限 2.4 检出限参考品L1 -L6 ，结果均为符合
主 1: 16
阳性，其中 L5 为 1: 16
阴性参考用企业阴性参考品检测，结果应均符合要求， IgM 和 IgG 企业阴性

5 2.5 符合
品符合率为阴性参考品 QI-Q20 均为阴性
阳性参考用企业阳性参考品检测，结果应均符合要求， IgM 和 IgG 企业阳性

6 2.6 符合

合率 IgM 100% IgG 100%
企业阴性参考品 Ql 阴性结果符
合率 IgM 100% Ig G1 00%
用 3 个不同批号的试剂(盒)分别符合率 IgMI00% IgGI00%
8 批间差 2.8 符合
次，各量级水平的阴阳性结果符合合率 IgM 100% IgG 100%
率均应不小于 95% 企业阴性参考品 Ql 阴性结果符
9 2.9 符合
状效应次，结果应不出现假阴性检测 IgG 企业阳性参考品 H ， 3
29
检验报告
批号 20200206
号项目条款结论 y王
IgM: 4mm
IgG: 4mm
IgM: 24 mmlmin
3 移行速度 2.3 移行速度应不低于 10 mm/min 符合
19G: 28 mmlmin
4 检出限 2 .4 检出限参考品L1 ~L6 ，结果均为符合
主1:1 6
阳性，其中 L5 为 1: 16
阴性参考用企业阴性参考品检测，结果应均符合要求， IgM 和 IgG 企业阴性

5 2.5 符合
品符合率为阴性参考品 Q1~Q20 均为阴性
阳性参考用企业阳性参考品检测，结果应均符合要求， IgM 和 IgG 企业阳性

6 2.6 符合
企业弱阳性参考品J2阳性结果
企业阴性参考品 Ql 阴性结果符
合率 19M 100% 19G 100%
用 3 个不同批号的试剂(盒)分别符合率 IgMI00% IgG100%
8 批间差 2.8 符合
次，各量级水平的阴阳性结果符合合率 IgM100% IgG 100%
率均应不小于 95% 企业阴性参考品 Q1 阴性结果符
9 2.9 符合
状效应次，结果应不出现假阴性检测 19G 企业阳性参考品 H ， 3
30
检验报告照片页
照片和说明
新型冠状病毒 (2019-nCoV) IgM/lgG 抗体联合检测试剂盒(肢体企法)
样品描述
试剂盒主要由检测卡和样本稀释液组成，其中检测卡由抗 2019-nCoV IgM 试条、抗 2019-nCoV IgG 试条和塑

料盒组成
型号规格或其它说明
10 人份/盒，批号 20200204
31
照片和说明
新型冠状病毒 (2019-nCoV) IgM/IgG 抗体联合检测试剂盒(肢体企法)
何\$〈。 F …自 ωE§ ￡\但由荆州相剧
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、
附4努唱 H
罢田窃以
mw
民刷
昭 NK
U刷
刊、
样品描述

料盒组成
10 人份/盒，批号 20200205
32
报告编号: MZ20140112 样品编号: MZ20140 1l 2 共 11 页第 10 页
照片和说明
新型冠状病毒 (2019-nCoV) IgM/lgG 抗体联合检测试剂盒(肢体金法)
伺宰〈。 FS
gh 口
gho\ 。"。
·
唱。剧。。"
u
\FNO
pnEa\酣蠕树酣甜食拇唔吐
U ωE32\
"。
NU
..
-
gc83\附甥国亩制
u
aNd
83·92摄
dz-3勘探咱也
。ZBt\
uduunω
牢固辅蜡剧
\田乱制
附暗 HH
摆\怅EE
、
样品描述

料盒组成
10 人份/盒，批号 20200206
33
检验报告附页
医疗器械产品技术要求预评价意见表
一、产品技术要求中性能指标的完整性与适用性;检验方法是否具有可操作性和
可重复性，是否与检验要求相适应.
该产品技术要求中的性能指标完整性和适用性基本合理;检验方法具有可操
作性，与检验要求相适应.
二、依据现行强制性或推荐性国家标准、行业标准检验的，所用强制性国家标准、
行业标准的完整性，所用标准与产品的适宜性，所用条款的适用性。
无.
三、如检验内容涉及引用中国药典的相关内容，其引用的完整性、适宜性和适用
性。
无。
四、其他需要说明的问题。
本产品技术要求预评价意见不含临床有效性的评价。
五、综合评价意见:
·经预评价，对产品技术要求无补充、完善意见。
口经预评价，产品技术要求在以下方面需要进一步补充、完善:
性能指标:
适用国家标准、行业标准:
引用《中华人民共和国药典》内容:
(医疗器械检测机构印章 )
2020';年 03 月 02 目
34
声明
广东省医疗器械质量监督检验所是具有独立法人资格、能够承担法律责任
的第三方公正检验机构，同时挂国家食品药品监督管理局广州医疗器械质量监
督检验中心、广东省食品药品监督管理局包装材料容器检验中心、广东省屁量
监督药品包装产品检验站和广东省质量监督医疗器械检验站的牌子。上述的"炳
中心和两站"与广东省医疗器械质量监督检验所是同一领导班子，组织机构、
人员、检验仪器设备等共享，在同一套管理体系下运行，根据下达任务的主管
部门或客户的要求，出具相应的检验报告，为社会提供公正的数据。
11
35
Inspection Report
Report Number:：MZ20140112
Commissioned Party:
Sample Name：
Model specifications 10 tests / box
Inspection category: Registration inspection (√)
Registration supplementary inspection ( )
Other inspections ( )
Guangdong Medical Devices Quality Surveillance and Test Institute

Guangzhou Medical Device Quality Supervision and Inspection Center of China
Food and Drug Administration
36
Notice
1. This report is invalid without the special seal of the inspection

report of this testing agency.
2. No part of this report may be copied without the approval of
this testing agency.
3. This report is invalid without the signature of the approver.
4. This report is invalid.
5. If there is any objection to this report, it should be submitted
to the inspection unit in writing within seven working days from
the date of receiving the report, and it will not be accepted after
the deadline.
6. This report is only responsible for incoming samples.
Address: No.1 Guangpuxi Road, Science City, Huangpu District,
Guangzhou
Inquiries: 020-66602388(daily) 020-66602531(supervised)
Fax: 020-66602400 (daily) 020-66602534 (supervised)
Postcode: 510663
Website：www.gdmdt.org.cn
E-mail: gdmitc-ywb@gdda.gov.cn
37
Guangzhou Medical Device Quality Supervision and Inspection Center of State Food
and Drug Administration
The Front Page of the Inspection Report
Report No.MZ20140112 Page 1 of 11
SARS-CoV-2IgM/IgG Combo Rapid Test Kit MZ20140112

Sample Nmae The Sample No.
Sample delivery（/） sampling（√）
Trademark / Model specifications 10 tests / box
Client Guangzhou Fenghua Bioengineering Co.,Ltd. Identify category Registration inspection
No.6 Yinyi Street,Guangzhou Economic and

Product Number /
Client address Technological Development 20200204、20200205、20200206
Lot Number
District,Guangdong,P.R.China
Production unit Guangzhou Fenghua Bioengineering Co.,Ltd. Sample number /
Unit under
Guangzhou Fenghua Bioengineering Co.,Ltd. Production Date 2020/02/04、2020/02/05、2020/02/06
inspection
Guangzhou Municipal Market Supervision

Sampling unit Number of samples 16 boxes each
Administration

Sampling location Sampling base /
Finished product cold storage
Sampling date 13/02/2020 Inspection location Zhongshan Inspection Room
Sample collection
20/02/2020 Inspection date 2020.02.20~2020.03.02
date
Test items Full project
The product technical requirements of SARS-CoV-2IgM/IgG Combo Rapid Test Kit issued by Guangzhou
Test Base
Fenghua Bioengineering Co.,Ltd.
Tested samples meet the technical requirements of SARS-CoV-2IgM/IgG Combo Rapid Test Kit issued by
Test Conclusion Conclusion: QUALIFIED.
（Special seal for inspection report or official seal of inspection unit）
Date of issue：05/03/2020
1）"——" in the report means this item is not applicable, and "/" in the report means this item is blank.
2）For reference information, see Appendix 1 on page 2 of the report and Appendix 2 on page 3 of the report. For
Remarks supplementary explanations of reference, see page 3 of the report.
3）For the pre-evaluation of the technical requirements of SARS-CoV-2 IgM/IgG Combo Rapid Test Kit issued by
Guangzhou Fenghua Bioengineering Co.,Ltd. see the attached page.
Approval： Audit： Inspection：

Duties： Authorized signatory
38
Guangzhou Medical Device Quality Supervision and Inspection Center of State Food and Drug Administration
Inspection Report
Report No.:MZ20140112 Samples No.: MZ20140112 Page 2 of 11
Table 1 Reference Information—Enterprise IgM References
No Reference Quantity Serial No. Description Lot. Resource Type Remark
The positive references L1-L6 are prepared by diluting the strong positive Guangdong 2nd All the negative references are tested
Detection
1 6 L1-L6 sample (1:32) with the sample diluents at 1:1, 1:2, 1:4, 1:8, 1:16 and 1:32, 20200203 Provincial Central Serum once, and the detection limit should be
limit
respectively. Hospital more than 1:16.
20 negative samples Q1-Q20, including a legialla pneumophagi(Q1), two
mycoplasma pneumonia(Q2,Q3), Q-Rickettsia(Q4),three Chlamydia

Guangdong 2nd All the negative references are tested
pneumonia(Q5,Q6,Q7), two adenovirus(Q8,Q9), a respiratory Syncytial
2 Negative 20 Q1-Q20 20200203 Provincial Central Serum once, and the result should be
virus(Q10), two influenza A virus(Q11,Q12), two influenza B
Hospital negative.
virus(Q13,Q14),two Para influenza virus(Q15,Q16), two rubella
virus(Q17,Q18) and two rhinovirus(Q19,Q20).
Guangdong 2nd All the positive references are tested

5 positive samples P1-P5, including a strong positive(1:16), two medium
3 Positive 5 P1-P5 20200203 Provincial Central Serum once, and the result should be
positive(1:8) and two weak positive(1:1).
Hospital positive.
All references are tested for 10 times

Guangdong 2nd
N:Q1,WP:J2, 3 samples, including a negative sample Q1 with legialla pneumophagi, a respectively. The coincidence rate of
4 Accuracy 3 20200203 Provincial Central Serum
P:J3 weak positive(1:1) J2 and a medium positive(1:8) J3. negative and positive results should
Hospital
not be less than 95%.
Guangdong 2nd No false negative results when testing
5 Hook effect 1 H A strong positive sample(1:64). 20200203 Provincial Central Serum the strong positive reference H
Hospital 3 times.
39
Inspection Report
Table 1 Reference Information—Enterprise IgG References
No Reference Quantity Serial No. Description Lot. Resource Type Remark
The positive references L1-L6 are prepared by diluting the strong positive Guangdong 2nd All the references are tested once, and
Detection
1 6 L1-L6 sample with the sample diluents at 1:1, 1:2, 1:4, 1:8, 1:16 and 1:32, 20200203 Provincial Central Serum the detection limit should be more
limit
respectively. Hospital than 1:16.
20 negative samples Q1-Q20, including a legialla pneumophagi(Q1), two
mycoplasma pneumonia(Q2,Q3), Q-Rickettsia(Q4),three Chlamydia

Guangdong 2nd All the negative references are tested
pneumonia(Q5,Q6,Q7), two adenovirus(Q8,Q9), a respiratory Syncytial
2 Negative 20 Q1-Q20 20200203 Provincial Central Serum once, and the result should be
virus(Q10), two influenza A virus(Q11,Q12), two influenza B
Hospital negative.
virus(Q13,Q14),two Para influenza virus(Q15,Q16), two rubella
virus(Q17,Q18) and two rhinovirus(Q19,Q20).
Guangdong 2nd All the positive references are tested

5 positive samples P1-P5, including a strong positive, two medium
3 Positive 5 P1-P5 20200203 Provincial Central Serum once, and the result should be
positive and two weak positive.
Hospital positive.
All references are tested for 10 times

Guangdong 2nd
N:Q1,WP:J2, 3 samples, including negative sample Q1 with legialla pneumophagi, a respectively. The coincidence rate of
4 Accuracy 3 20200203 Provincial Central Serum
P:J3 weak positive J2 and a medium positive J3. negative and positive results should
Hospital
not be less than 95% respectively.
Guangdong 2nd No false negative results when testing
5 Hook effect 1 H A strong positive sample with with the sample diluents at 1:64 20200203 Provincial Central Serum the strong positive reference H for
Hospital 3 times.
40
Inspection Report
Supplementary notes to the reference crystal information sheet:

1.The SARS-CoV-2IgM/IgG Combo Rapid Test Kit was tested positive for the positive samples, and the samples were diluted by 1:1,1:2,1:4,1:8,1:16,1:32,1:64
dilution ratio. The positive samples were more than or equal to 1:16, and the positive samples were strong positive, and the dilution rate was 1:2 < three. The
positive samples are medium positive; the positive samples with the proportion of original times ≤ dilution < 1:2 are weak positive.
2. the detection limit reference has been pre diluted with sample diluents, which is used directly during the detection. It is not necessary to add the sample diluents to
mix well according to the instructions before use. In addition to the detection limit reference products, other reference products shall be used according to the
instructions.
41
Inspection Report
Lot: 20200204
No Item Standard No. Standard Requirement Test Result Conclusion Remark
The outer package should be intact and undamaged, the label should
1 Appearance 2.1 Meet the requirements. Compatible
be clear and legible, and the liquid reagent should be free of impurities.
2 Width of Membrane 2.2 The width of membrane should be wider than 3mm. IgM:4mm;IgG:4mm Compatible
3 Migration Speed 2.3 Liquid migration speed should be not lower than 10mm/min. IgM:21mm/min;IgG:23mm/min Compatible
Meet the requirements. All the references L1-L6 are tested as positive. And the
4 Detection Limit 2.4 The detection limit of all the references should be more than 1:16. Compatible
L5 is 1:16.
Coincidence Rate of Meet the requirements. All the IgM and IgG negative references Q1-Q20 are
5 2.5 All the negative references should be tested as negative. Compatible
Negative References tested as negative.
Coincidence Rate of Meet the requirements. All the IgM and IgG positive references are tested as
6 2.6 All the positive references should be tested as positive. Compatible
Positive References positive.
The coincidence rate of the weak positive reference J2 are 100%(IgM) and
The negative reference, weak positive reentrance and positive
100%(IgG).The coincidence rate of the enterprise positive reference J3 are
7 Repeatability 2.7 reference are tested for 10 times respectively. The coincidence rate of Compatible
100%(IgM) and 100%(IgG). The coincidence rate of the
negative and positive results should not be less than 95% respectively.
enterprise negative reference Q1 are 100%(IgM) and 100%(IgG).
The weak positive and positive references are tested by 3 different The coincidence rate of the weak positive reference are 100%(IgM) and
8 Batch Variation 2.8 batches of the reagents. The coincidence rate of negative and positive 100%(IgG).The coincidence rate of the positive reentrance are 100%(IgM) and Compatible
results should be not less than 95% respectively. 100%(IgG).
The enterprise IgM positive reference (H) is tested as positive for 3 times.The
9 Hook effect 2.9 The strong positive reference is tested as positive for 3 times. Compatible
enterprise IgG positive reference (H) is tested as positive for 3 times.
42
Inspection Report
Lot: 20200205
The detection limit of all the enterprise references should be more than Meet the requirements. All the enterprise references L1-L6 are tested as positive.
4 Detection Limit 2.4 Compatible
1:16. And the L5 is 1:16.
Coincidence Rate of Meet the requirements. All the enterprise IgM and IgG negative references
5 2.5 All the enterprise negative references should be tested as negative. Compatible
Negative References Q1-Q20 are tested as negative.
Coincidence Rate of Meet the requirements. All the enterprise IgM and IgG positive references are
6 2.6 All the enterprise positive references should be tested as positive. Compatible
Positive References tested as positive.
The weak positive and positive references are tested by 3 different The coincidence rate of the weak positive reentrance are 100%(IgM) and
8 Batch Variation 2.8 batches of the reagents. The coincidence rate of negative and positive 100%(IgG).The coincidence rate of the positive reentrance are 100%(IgM) and Compatible
results should be not less than 95% respectively. 100%(IgG).
The enterprise IgM positive reference H is tested as positive for 3 times.The

enterprise IgG positive reference H is tested as positive for 3 times.
43
Inspection Report
Lot: 20200206
The detection limit of all the enterprise references should be more than Meet the requirements. All the enterprise references L1-L6 are tested as
4 Detection Limit 2.4 Compatible
1:16. positive. And the L5 is 1:16.
Coincidence Rate of Meet the requirements. All the enterprise IgM and IgG negative references
5 2.5 All the enterprise negative references should be tested as negative. Compatible
Negative References Q1-Q20 are tested as negative.
Coincidence Rate of Meet the requirements. All the enterprise IgM and IgG positive references
6 2.6 All the enterprise positive references should be tested as positive. Compatible
Positive References are tested as positive.
The weak positive and positive references are tested by 3 different The coincidence rate of the weak positive reentrance are 100%(IgM) and
8 Batch Variation 2.8 batches of the reagents. The coincidence rate of negative and positive 100%(IgG).The coincidence rate of the positive reentrance are 100%(IgM) Compatible
results should be not less than 95% respectively. and 100%(IgG).
The enterprise IgM positive reference H is tested as positive for 3 times.The

enterprise IgG positive reference H is tested as positive for 3 times.
44

Photos and instructions

Sample description
The kit is mainly composed of test card and sample diluent, wherein the test card consists of anti
2019-nCoV IgM test strip, anti 2019-nCoV IgG test strip and plastic
Material box composition
Model, specification or other description
10 tests/box, Batch: 20200204
45


SARS-CoV-2IgM/IgG Combo Rapid Test Kit
Sample description
10tests/box, Batch: 20200205
46


SARS-CoV-2IgM/IgG Combo Rapid Test Kit
Sample description
10tests/box, Batch: 20200206
47
The Attached Page of the Inspection Report
The Report No.MZ20140112 The Sample No. MZ20140112 Page 11 of 11
Medical device product technical requirements pre-evaluation opinion Form
1. The completeness and applicability of performance indicators in product technical requirements;

whether the inspection method is operable and repeatable, and whether it is compatible with the
inspection requirements.
The completeness and applicability of the performance indicators in the technical
requirements of this product are basically reasonable; the inspection method is operable and is
compatible with the inspection requirements.
2. In accordance with the current mandatory or recommended national standards and industry
standards, the integrity of the mandatory national standards and industry standards used, the
suitability of the standards and products used, and the applicability of the terms used.
None
3. If the inspection content involves quoting relevant content of the Chinese Pharmacopoeia, the
completeness, suitability and applicability of the quotation.
None
4. Other issues that need to be explained.
The pre-evaluation opinions on the technical requirements of this product do not include the
evaluation of clinical effectiveness.
5. Comprehensive evaluation opinions:
■After pre-evaluation, there is no supplement and perfect opinion on product technical
requirements.
□After pre-evaluation, the product technical requirements need to be further supplemented
and improved in the following aspects:
Performance:
Applicable national standards and industry standards:
To quote the content of "The Pharmacopoeia of the People's Republic of China":
(Seal of medical device testing organization)

02/03/2020
48
Declaration
Guangdong Medical Device Quality Surveillance and Test

Institute is a third-party impartial test institute with independent
legal personality and legal responsibility. It also hangs
Guangzhou Medical Device Quality Surveillance and Test
Institute center of Nation Food and Medical Administration,
packaging material container test center of Guangdong Food and
Medical Administration, Guangdong quality Surveillance and
drug packaging product test station and Guangdong quality
Surveillance of the brand of medical device test station. The
"two centers and two stations" mentioned above are the same
leading group as Guangdong Medical Device Quality
Surveillance and Test Institute, with organizations, personnel,
test instruments and equipment sharing, operating under the
same set of management system, issuing corresponding
inspection reports according to the requirements of the
competent department or customers who assigned tasks, so as to
provide fair data for the society.
49
50
51
52
53
54

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广州市丰华生物工程有限公司

Guangzhou Fenghua Bioengineering Co.,Ltd.

1.1 产品彩页Product Brochure···················1

1.2 使用指南 Instruction for Use··················3

1.3 包装规格 Package Scheme······················5

1.4 产品说明书Kit Inserts···························9

2.1 医保商会白名单Free Sale Certificate················11

2.2 CE-IVD 证书CE-IVD Certificate··············14

2.3 美国 FDA 紧急使用（EUA）证明FDA EUA Certification····18

VerificationReport Issued by Guangdong Medical Devices

Quality Surveillance and Test Institute·················22

2.5 货物运输条件鉴定书Certification for Transport of

Rapid results in 15 min.

* Refer to the instruction manual for further details.

Guangzhou Fenghua Bioengineering Co.,Ltd. No. 6 Yinyi Street , Guangzhou

Guangzhou Fenghua Bioengineering Co.,Ltd.

Guangzhou Fenghua Bioengineering Co.,Ltd.

Box size: 250mm*165mm*70mm;

Box weight: 642g;

Carton size: 635mm*490mm*358mm;

Carton weight: 13.0 kg;

Box size: 235mm*160mm*120mm;

Box weight: 860g;

Carton size: 635mm*490mm*358mm;

Carton weight: 12.5 kg;

Box size: 150mm*148mm*70mm;

Box weight: 300g;

Carton size: 635mm*490mm*358mm;

Carton weight: 12.2 kg;

Box size: 120mm*70mm*20mm;

Box weight: 31.60g;

 1×Alcohol Prep Pads;

Carton size: 635mm*490mm*358mm;

Carton weight: 10.5 kg;

Guangzhou Fenghua Bioengineering Co吁Ltd.

No.6 Yinyi Street, Guangzhou Economic and Technological

Development Dis位ict, Guangdong, P. R. China

Product(s): SARS-Co -2 IgM/IgG Combo Rapid Test Kit

4φd石〈 Issued: Ap 民 02 2020

This is not a CE mark and is only

样品名称新型冠状病 毒 (2019-nCoV) IgM/ IgG 抗体联合检

咨询电话 020-66602388 (日常检验)、 020-66602531 (监督抽验)

传 真 020-66602400 (日常检验)、 020-66602534 (监督抽验)

网站 www. gdmd t. org. cn

新型冠状病毒 (2019-nCoV) IgMlIgG 抗

委托方 广州市丰华生物工程有限公司 检验类别 注册检验

抽样臼期 2020 年 02 月 13 日 检验地点 中山检验室

广州市丰华生物工程有限公司发布的《新型冠状病毒( 20 19-nCoV ) 19M/lgG 抗体联合检

签发日 期: ~02.o..:年 03月 05 日

附表 1 参考品信息表- '1 11 M 企业参考品

附表 2 参考品信息表- I且G 企业参考品

①抗 2019-nCoVlgG 阳性样本 ， 其中 PI 为强阳性{稀释比 广东省

抗 20 I 9-nCoV IgG 阴性样本 l 份，为含嗜肺军团菌的交叉样 检测阴性、弱阳、阳性精

阴性参考 用企业阴性参考品检测，结果应均 符合要求， lgM 和 IgG 企业阴性

阳性参考 用企业阳性参考品检测，结果应均 符合要求， lgM 和 IgG 企业阳性

阴性参考 用企业阴性参考品检测，结果应均 符合要求， IgM 和 IgG 企业阴性

阳性参考 用企业阳性参考品检测，结果应均 符合要求， IgM 和 IgG 企业阳性

Box size: 250mm165mm70mm;

Carton size: 635mm490mm358mm;

Box size: 235mm160mm120mm;

Carton size: 635mm490mm358mm;

Box size: 150mm148mm70mm;

Carton size: 635mm490mm358mm;

Box size: 120mm70mm20mm;

Carton size: 635mm490mm358mm;

样品名称新型冠状病毒 (2019-nCoV) IgM/ IgG 抗体联合检

传真 020-66602400 (日常检验)、 020-66602534 (监督抽验)

委托方广州市丰华生物工程有限公司检验类别注册检验

抽样臼期 2020 年 02 月 13 日检验地点中山检验室

签发日期: ~02.o..:年 03月 05 日

①抗 2019-nCoVlgG 阳性样本，其中 PI 为强阳性{稀释比广东省

抗 20 I 9-nCoV IgG 阴性样本 l 份，为含嗜肺军团菌的交叉样检测阴性、弱阳、阳性精

阴性参考用企业阴性参考品检测，结果应均符合要求， lgM 和 IgG 企业阴性

阳性参考用企业阳性参考品检测，结果应均符合要求， lgM 和 IgG 企业阳性

阴性参考用企业阴性参考品检测，结果应均符合要求， IgM 和 IgG 企业阴性

阳性参考用企业阳性参考品检测，结果应均符合要求， IgM 和 IgG 企业阳性

企业弱阳性参考品 J2 阳性结果

阴性参考用企业阴性参考品检测，结果应均符合要求， IgM 和 IgG 企业阴性

阳性参考用企业阳性参考品检测，结果应均符合要求， IgM 和 IgG 企业阳性