Inzek International Trading

www.inzek.nl
info@inzek.nl
Tel: +31 (0)55 7620786

Ref No:BZ200318
LETTER OF AUTHORIZATION Apeldoorn, 18th Mar 2020,

To Whom It May Concern,

We, Inzek International Trading B.V, In Vitro Diagnostics manufacturing company with our principal
business address at Vissenstraat 32, 7324AL, Apeldoorn city, The Netherlands, phone 0031-55-7620786,
established and organized under the laws of Kingdom of the Netherlands. Hereby authorize Mach-E BV.
Company with principal business address at Boekweitskorrel 3, 1251ZH- Laren, The Netherlands Tel No.+316
11001450 , organized and existing under the laws of Kingdom Of Netherlands , to act as our distributor for
registering, promoting, marketing, selling, participating in Tenders, as well as rendering installation,
commissioning, training and after sales services for the BIOZEK BNCP-402 COVID-19 rapid test cassette in
INDONESIA, as of March 18, 2020.
This Letter of Authorization is valid from above mentioned date and its validity will extend until December
the 31st, 2020, unless earlier terminated upon three (3) months written notice.

Sincerely,

Inzek International Trading B.V

Zaki Hamid-General Manager Apeldoorn, 18-03-2020

Inzek International Trading B.V, Vissenstraat 32 , 7324AL , Apeldoorn , The Netherlands

 COVID-19 IgG/IgM Rapid Test Cassette specimens may be stored at 2-8°C for up to 7 days, for long term storage, serum/plasma 【LIMITATIONS】
specimens should be kept below -20°C. Whole blood collected by venipuncture should be 1. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is for in vitro
(Whole Blood/Serum/Plasma) stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood diagnostic use only. This test should be used for detection of IgG and IgM antibody to
Package Insert specimens. Whole blood collected by fingerstick should be tested immediately. COVID-19 in whole blood, serum or plasma specimens. Neither the quantitative value nor the
 Bring specimens to room temperature prior to testing. Frozen specimens must be completely rate of increase in the concentration of IgG or IgM antibodies to COVID-19 can be determined
REF BNCP-402 English thawed and mixed well prior to testing. Specimens should not be frozen and thawed by this qualitative test.
A rapid test for the qualitative detection of IgG and IgM antibodies to COVID-19 in human whole repeatedly. 2. The COVID-19 IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma) will only indicate
blood, serum or plasma specimens.  If specimens are to be shipped, they should be packed in compliance with local regulations the presence of IgG and IgM antibodies to COVID-19 in the specimen and should not be
For professional in vitro diagnostic use only. covering the transportation of etiological agents. used as the sole criteria for the diagnosis of COVID-19 infections.
【INTENDED USE】  EDTA K2, Heparin sodium, Citrate sodium and Potassium Oxalate can be used as the 3. As with all diagnostic tests, all results must be considered with other clinical information
The COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for anticoagulant for collecting the specimen. available to the physician.
the qualitative detection of IgG and IgM antibodies to COVID-19 in human whole blood, serum or 【MATERIALS 】 4. If the test result is negative and clinical symptoms persist, additional follow-up testing using
plasma specimen. Materials Provided other clinical methods is suggested. A negative result at any time does not preclude the
【SUMMARY】  Test cassettes  Droppers  Package insert  Buffer possibility of COVID-19 infection.
Early January 2020, a novel coronavirus (COVID-19) was identified as the infectious agent causing an Materials Required But Not Provided 5. The hematocrit level of the whole blood can affect the test results. Hematocrit level needs to
outbreak of viral pneumonia in Wuhan, China, where the first cases had their symptom onset in  Specimen Collection Containers  Centrifuge (for plasma only) be between 25% and 65% for accurate results.
1
December 2019.  Lancets (for fingerstick whole blood only)  Timer 【PERFORMANCE CHARACTERISTICS】
Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals,  Capillary Tubes  Pipette Sensitivity and Specificity
2
and birds and that cause respiratory, enteric, hepatic, and neurologic diseases. Six coronavirus species 【DIRECTIONS FOR USE】 The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) was compared with a
3
are known to cause human disease. Four viruses — 229E, OC43, NL63, and HKU1 — are prevalent Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior leading commercial PCR; the results show that COVID-19 IgG/IgM Rapid Test Cassette (Whole
3
and typically cause common cold symptoms in immunocompetent individuals. The two other strains — to testing. Blood/Serum/Plasma) has a high sensitivity and specificity.
severe acute respiratory syndrome coronavirus (SARS-COV) and Middle East respiratory syndrome 1. Remove the test cassette from the foil pouch and use it within one hour. Best results will be IgG Result
coronavirus (MERS-COV) — are zoonotic in origin and have been linked to sometimes fatal illness.
4 obtained if the test is performed immediately after opening the foil pouch. Method PCR
2. Place the cassette on a clean and level surface. Total Results
Coronaviruses are zoonotic, meaning they are transmitted between animals and people. Results Positive Negative
For Serum or Plasma specimen: COVID-19 IgG/IgM
Common signs of infection include respiratory symptoms, fever, cough, shortness of breath and Positive 20 1 21
 To use a dropper: Hold the dropper vertically, draw the specimen to the fill line Rapid Test Cassette
breathing difficulties. In more severe cases, infection can cause pneumonia, severe acute respiratory Negative 0 49 49
5 (approximately 10L), and transfer the specimen to the specimen well (S), then add 2 Total Results 20 50 70
syndrome, kidney failure and even death. drops of buffer (approximately 80 L), and start the timer.
Standard recommendations to prevent infection spread include regular hand washing, covering mouth Relative Sensitivity: 100% (95%CI*: 86.0%-100%) *Confidence Interval
 To use a pipette: To transfer 10 L of specimen to the specimen well(S), then add 2 drops
and nose when coughing and sneezing, thoroughly cooking meat and eggs. Avoid close contact with Relative Specificity: 98.0% (95%CI*: 89.4%-99.9%)
of buffer (approximately 80 L), and start the timer
anyone showing symptoms of respiratory illness such as coughing and sneezing.
5 Overall Accuracy: 98.6% (95%CI*: 92.3%-99.96%)
For Venipuncture Whole Blood specimen:
IgM Result
【PRINCIPLE】  To use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the fill
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative Method PCR
line and transfer 1 full drop (approx. 20μL) of specimen to the sample well(S). Then add 2 Total Results
membrane-based immunoassay for the detection of IgG and IgM antibodies to COVID-19 in drops of buffer (approximately 80 L) and start the timer. Results Positive Negative
COVID-19 IgG/IgM
whole blood, serum or plasma specimen. This test consists of two components, an IgG  To use a pipette: To transfer 20 L of whole blood to the specimen well(S), then add 2 Positive 17 2 19
Rapid Test Cassette
component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test drops of buffer (approximately 80 L), and start the timer Negative 3 48 51
line region. During testing, the specimen reacts with COVID-19 antigen-coated particles in the For Fingerstick Whole Blood specimen: Total Results 20 50 70
test cassette. The mixture then migrates upward on the membrane chromatographically by  To use a dropper: Hold the dropper vertically, draw the specimen about 1 cm above the fill Relative Sensitivity: 85.0% (95%CI*: 62.1%-96.8%) *Confidence Interval
capillary action and reacts with the anti-human IgG in IgG test line region, if the specimen line and transfer 1 full drop (approx. 20μL) of specimen to the sample well(S). Then add 2 Relative Specificity: 96.0% (95%CI*: 86.3%-99.5%)
contains IgG antibodies to COVID-19. A colored line will appear in IgG test line region as a result drops of buffer (approximately 80 L) and start the timer. Overall Accuracy: 92.9% (95%CI*: 84.1%-97.6%)
of this. Similarly, anti-human IgM is coated in IgM test line region and if specimen contains IgM  To use a capillary tube: Fill the capillary tube and transfer approximately 20L of Cross-Reactivity
antibodies to COVID-19, the conjugate-specimen complex reacts with anti-human IgM. A colored fingerstick whole blood specimen to the specimen well (S) of test cassette, then add 2 The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) has been tested for
line appears in IgM test line region as a result. drops of buffer (approximately 80 L) and start the timer. See illustration below. anti-influenza A virus, anti-influenza B virus, anti-RSV, anti-Adenovirus, HBsAg, anti-Syphilis,
Therefore, if the specimen contains COVID-19 IgG antibodies, a colored line will appear in IgG 3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result anti-H. Pylori, anti-HIV and anti-HCV positive specimens. The results showed no cross-reactivity.
test line region. If the specimen contains COVID-19 IgM antibodies, a colored line will appear in after 20 minutes. Interfering Substances
IgM test line region. If the specimen does not contain COVID-19 antibodies, no colored line will Note: It is suggested not to use the buffer, beyond 6 months after opening the vial. The following compounds have been tested using the COVID-19 IgG/IgM Rapid Test Cassette
appear in either of the test line regions, indicating a negative result. To serve as a procedural (Whole Blood/Serum/Plasma) and no interference was observed.
control, a colored line will always appear in the control line region, indicating that the proper Triglyceride: 50 mg/dL
volume of specimen has been added and membrane wicking has occurred. Ascorbic Acid: 20mg/dL
【REAGENTS】 Hemoglobin 1000mg/dL
The test contains anti-human IgM and anti-human IgG as the capture reagent, COVID-19 Bilirubin: 60mg/dL
antigen as the detection reagent. A goat anti-mouse IgG is employed in the control line system. Total cholesterol : 6mmol/L
【PRECAUTIONS】 【BIBLIOGRAPHY】
1. For professional in vitro diagnostic use only. Do not use after expiration date. 1. World Health Organization (WHO). WHO Statement Regarding Cluster of Pneumonia Cases
2. Do not eat, drink or smoke in the area where the specimens or kits are handled. in Wuhan, China. Beijing: WHO; 9 Jan 2020. [Accessed 26 Jan
3. Do not use test if pouch is damaged. 2020]. https://www.who.int/china/news/detail/09-01-2020-who-statement-regarding-cluster-of-
4. Handle all specimens as if they contain infectious agents. Observe established precautions pneumonia-cases-in-wuhan-china
against microbiological hazards throughout all procedures and follow the standard procedures 2. Weiss SR, Leibowitz JL. Coronavirus pathogenesis. Adv Virus Res 2011;81:85-164.
for proper disposal of specimens. PMID:22094080 DOI:10.1016/B978-0-12-385885-6.00009-2
5. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when 3. Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of
specimens are assayed. coronaviruses. Trends Microbiol 2016;24:490-502.
6. Please ensure that an appropriate amount of samples are used for testing. Too much or too PMID:27012512 DOI:10.1016/j.tim.2016.03.003
little sample size may lead to deviation of results. 4. Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev
7. The used test should be discarded according to local regulations. Microbiol 2019;17:181-192.PMID:30531947 DOI:10.1038/s41579-018-0118-9
8. Humidity and temperature can adversely affect results. 5. World Health Organization (WHO). Coronovirus. https://www.who.int/health-
【STORAGE AND STABILITY】 topics/coronavirus
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The test is
stable through the expiration date printed on the sealed pouch. The test must remain in the 【INTERPRETATION OF RESULTS】
sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date. IgG POSITIVE:* Two colored lines appear. One colored line should always appear in the
【SPECIMEN COLLECTION AND PREPARATION】 control line region (C) and another line should be in the IgG line region.
 The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) can be performed IgM POSITIVE:* Two colored lines appear. One colored line should always appear in the
using whole blood (from venipuncture or fingerstick), serum or plasma. control line region (C) and another line should be in the IgM line region.
 To collect Fingerstick Whole Blood Specimens: IgG and IgM POSITIVE:* Three colored lines appear. One colored line should always appear
 Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to in the control line region (C) and two test lines should be in the IgG line region and IgM line
dry. region.
 Massage the hand without touching the puncture site by rubbing down the hand towards *NOTE: The intensity of the color in the test line regions may vary depending on the Inzek International Trading
the fingertip of the middle or ring finger. concentration of COVID-19 antibodies present in the specimen. Therefore, any shade of color in Vissenstraat 32
 Puncture the skin with a sterile lancet. Wipe away the first sign of blood. the test line region should be considered positive. 7324 AL
 Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture NEGATIVE: One colored line appears in the control line region (C). No line appears in the Apeldoorn
The Netherlands
site. IgG region and IgM region.
 Add the Fingerstick Whole Blood specimen to the test by using a capillary tube or INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural
droppers provided: techniques are the most likely reasons for control line failure. Review the procedure and repeat
 Touch the end of the capillary tube to the blood until filled to approximately 20L. the test with a new test. If the problem persists, discontinue using the test kit immediately and
Avoid air bubbles. contact your local distributor. Number: 199015301
 Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear 【QUALITY CONTROL】
non-hemolyzed specimens. Internal procedural control is included in the test. A colored line appearing in the control region Effective Date: 2020-02-xx
 Testing should be performed immediately after the specimens have been collected. Do not (C) is an internal procedural control. It confirms sufficient specimen volume and correct
leave the specimens at room temperature for prolonged periods. Serum and plasma procedural technique.
 Inzek International Trading B.V.

Clinical Study Report of

2019-nCoV IgG/IgM Rapid
Test Cassette
Ref.: BNCP-402/BNCP-402S

Name Department Date

Prepared by Tomy Panga R&D 2020.02.13
Reviewed by Kael Chan R&D 2020.02.13
 Inzek International Trading B.V.

Content
1. Purpose................................................................................................................................. 3

2. Materials .............................................................................................................................. 3

3. Operation Method ............................................................................................................ 3

4. Test Results ......................................................................................................................... 3

5. Result Analysis .................................................................................................................. 5

6. Conclusion ........................................................................................................................... 8

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 Inzek International Trading B.V.

1. Purpose
Do clinical studies of 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
with the 2019-nCoV positive specimen and negative specimen which confirmed with PCR
method.

2. Materials
▪ 2019-nCoV Rapid Test Cassette Lot: COV20020001-R
▪ 2019-nCoV Rapid Test Cassette single use kit Lot: COV20020002-R
▪ 20 2019-nCoV clinical positive specimen
▪ 50 2019-nCoV clinical negative specimen

3. Operation Method
3.1. Place the cassette on a clean and level surface. Hold the dropper vertically, transfer 10μL
serum, plasma specimen or 20μL whole blood specimen to the sample well(S). Then add
2 drops of buffer (approximately 80 L) and start the timer.
3.2. Read the results at 10 minutes, do not interpret the results after 20 minutes.

4. Test Results
Table- Test Results of BNCP-402
Result
No. Gender Age AllTest Kit
PCR Results
IgG IgM
1 Female 45 + + +
2 Female 34 + + +
3 Male 31 + + +
4 Male 36 + + +
5 Female 55 + + +
6 Female 63 + + +
7 Female 38 + + +
8 Male 74 + + +
9 Male 74 + - +
10 Male 51 + + +
11 Male 83 + - +
12 Female 65 + + +
13 Female 59 + + +
14 Female 48 + + +
15 Male 36 + + +
16 Female 81 + - +
17 Male 85 + + +
18 Male 39 + + +
13-2-2020

19 Female 84 + + +
20 Male 91 + + +

3
 Inzek International Trading B.V.
21 Male 39 - - -
22 Female 80 - - -
23 Female 96 - - -
24 Male 85 - - -
25 Female 77 - - -
26 Female 71 - - -
27 Male 51 - - -
28 Female 73 - + -
29 Male 74 - - -
30 Female 26 - - -
31 Female 60 - - -
32 Male 67 - - -
33 Male 38 - - -
34 Male 82 - - -
35 Female 63 - - -
36 Male 90 - - -
37 Female 69 - - -
38 Male 56 - - -
39 Male 68 + - -
40 Male 59 - - -
41 Female 66 - - -
42 Female 17 - - -
43 Female 85 - - -
44 Male 31 - - -
45 Female 68 - - -
46 Male 59 - - -
47 Female 71 - - -
48 Male 36 - - -
49 Male 39 - + -
50 Male 82 - - -
51 Female 49 - - -
52 Male 62 - - -
53 Male 71 - - -
54 Female 38 - - -
55 Male 82 - - -
56 Female 63 - - -
57 Male 74 - - -
58 Male 69 - - -
59 Male 56 - - -
60 Female 68 - - -
13-2-2020

61 Male 59 - - -
62 Female 46 - - -
63 Female 17 - - -

4
 Inzek International Trading B.V.
64 Male 85 - - -
65 Female 31 - - -
66 Male 68 - - -
67 Male 52 - - -
68 Female 81 - - -
69 Male 66 - - -
70 Female 27 - - -
Note： “+” mean positive result, “-” mean negative result

Table- Test Results of BNCP-402S

Result
No. Gender Age AllTest Kit
PCR Results
IgG IgM
1 Female 45 + + +
2 Female 34 + + +
3 Male 31 + + +
4 Male 36 + + +
5 Female 55 + + +
6 Female 63 + + +
7 Female 38 + + +
8 Male 74 + + +
9 Male 74 + - +
10 Male 51 + + +
11 Male 83 + - +
12 Female 65 + + +
13 Female 59 + + +
14 Female 48 + + +
15 Male 36 + + +
16 Female 81 + - +
17 Male 85 + + +
18 Male 39 + + +
19 Female 84 + + +
20 Male 91 + + +
21 Male 39 - - -
22 Female 80 - - -
23 Female 96 - - -
24 Male 85 - - -
25 Female 77 - - -
26 Female 71 - - -
27 Male 51 - - -
13-2-2020

28 Female 73 - + -
29 Male 74 - - -
30 Female 26 - - -

5
 Inzek International Trading B.V.
31 Female 60 - - -
32 Male 67 - - -
33 Male 38 - - -
34 Male 82 - - -
35 Female 63 - - -
36 Male 90 - - -
37 Female 69 - - -
38 Male 56 - - -
39 Male 68 + - -
40 Male 59 - - -
41 Female 66 - - -
42 Female 17 - - -
43 Female 85 - - -
44 Male 31 - - -
45 Female 68 - - -
46 Male 59 - - -
47 Female 71 - - -
48 Male 36 - - -
49 Male 39 - + -
50 Male 82 - - -
51 Female 49 - - -
52 Male 62 - - -
53 Male 71 - - -
54 Female 38 - - -
55 Male 82 - - -
56 Female 63 - - -
57 Male 74 - - -
58 Male 69 - - -
59 Male 56 - - -
60 Female 68 - - -
61 Male 59 - - -
62 Female 46 - - -
63 Female 17 - - -
64 Male 85 - - -
65 Female 31 - - -
66 Male 68 - - -
67 Male 52 - - -
68 Female 81 - - -
69 Male 66 - - -
70 Female 27 - - -
13-2-2020

Note： “+” mean positive result, “-” mean negative result

6
 Inzek International Trading B.V.

5. Result Analysis
Table: Clinical study result of BNCP-402
IgG Result
Method PCR
Total Results
2019-nCoV IgG/IgM Results Positive Negative
Rapid Test Cassette Positive 20 1 21
(WB/S/P) Negative 0 49 49
Total Results 20 50 70
Relative Sensitivity: ＞99.9% (95%CI*: 86%-100%)
Relative Specificity: 98.0% (95%CI*: 89.4%-99.9%)
Accuracy: 98.6% (95%CI*: 92.3%-99.96%) *Confidence Intervals
IgM Result
Method PCR
Total Results
2019-nCoV IgG/IgM Results Positive Negative
Rapid Test Cassette Positive 17 2 19
(WB/S/P) Negative 3 48 51
Total Results 20 50 70
Relative Sensitivity: 85.0% (95%CI*: 62.1%-96.8%)
Relative Specificity: 96.0% (95%CI*: 86.3%-99.5%)
Accuracy: 92.9% (95%CI*: 84.1%-97.6%) *Confidence Intervals

Table: Clinical study result of BNCP-402S

IgG Result
Method PCR
Total Results
2019-nCoV IgG/IgM Results Positive Negative
Rapid Test Cassette Positive 20 1 21
(Fingerstick Whole
Negative 0 49 49
Blood)
Total Results 20 50 70
Relative Sensitivity: ＞99.9% (95%CI*: 86%-100%)
Relative Specificity: 98.0% (95%CI*: 89.4%-99.9%)
Accuracy: 98.6% (95%CI*: 92.3%-99.96%) *Confidence Intervals
IgM Result
Method PCR
Total Results
2019-nCoV IgG/IgM Results Positive Negative
Rapid Test Cassette Positive 17 2 19
(Fingerstick Whole
Negative 3 48 51
13-2-2020

Blood)
Total Results 20 50 70
Relative Sensitivity: 85.0% (95%CI*: 62.1%-96.8%)

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 Inzek International Trading B.V.
Relative Specificity: 96.0% (95%CI*: 86.3%-99.5%)
Accuracy: 92.9% (95%CI*: 84.1%-97.6%) *Confidence Intervals

6. Conclusion
The relative sensitivity of 2019-nCoV IgG/IgM Rapid Test Cassette (BNCP-402 and BNCP-402S)
was more than 99.9% for IgG and 85.0% for IgM, the relative specificity was 98.0% for IgG and
96.0% for IgM compare with PCR result.

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8
 Certificate of Approval
This is to certify that the Management System of:

Inzek International Trading B.V.

Vissenstraat 32, 7324 AL Apeldoorn, Netherlands
has been approved by LRQA to the following standards:
ISO 13485:2016

P.G. Cornelissen - Area Manager North Europe

Issued by: Lloyd's Register Nederland B.V.
for and on behalf of: Lloyd's Register Quality Assurance Limited

Current issue date: 9 March 2019 Original approval(s):

Expiry date: 8 March 2022 ISO 13485 – 9 March 2019
Certificate identity number: 10177988

Approval number(s): ISO 13485 – 00019238

The scope of this approval is applicable to:

Design, development, production and distribution of In Vitro Diagnostics Medical device - reagents and
instrument for point of care testing.

Lloyd's Register Group Limited, its affiliates and subsidiaries, including Lloyd's Register Quality Assurance Limited (LRQA), and their respective officers, employees or agents are, individually and collectively, referred to in this clause as
'Lloyd's Register'. Lloyd's Register assumes no responsibility and shall not be liable to any person for any loss, damage or expense caused by reliance on the information or advice in this document or howsoever provided, unless that
person has signed a contract with the relevant Lloyd's Register entity for the provision of this information or advice and in that case any responsibility or liability is exclusively on the terms and conditions set out in that contract.
Issued by: Lloyd's Register Nederland B.V., K.P. van der Mandelelaan 41a 3062MB Rotterdam Netherlands for and on behalf of: Lloyd's Register Quality Assurance Limited, 1 Trinity Park, Bickenhill Lane, Birmingham B37 7ES, United
Kingdom

Page 1 of 1
 Zertifikat – Certificate – Certificaat – Certificado – Certificat – Sertifika – ‫ – شهادة‬сертификат - Certifikat
EC Declaration of Conformity

Manufacturer:
Name: Inzek International Trading
Address: Vissenstraat 32, 7324AL – Apeldoorn, The Netherlands

Product Name and Models(s):

COVID-19 IgM/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
REF BNCP-402
Classification: Other Device of IVDD 98/79/EC
Conformity Assessment Route: IVDD 98/79/EC Annex III
EDMA Code: 15 70 90 90 00

We herewith declare that the above mentioned products meet the transposition into national
law, the provisions of the following EC Council Directives and Standards.
DIRECTIVES
General applicable directives:
DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27
October 1998 on in vitro diagnostic medical devices

Standard Applied: EN ISO13485:2016, EN ISO14971:2012, EN 13975:2003, EN ISO 18113-1:2011,

EN ISO 18113-2:2011, EN 13612:2002/AC:2002, EN ISO 17511:2003, EN ISO 23640:2015, EN
ISO, EN 13641:2002, ISO 15223-1:2012

After preparation of the necessary technical documentation as well as the conformity

declaration the required CE marking can be affixed on the product. Other relevant
directives must be observed.

Place, Date of Issue: Apeldoorn on 20/02/2020

Signature: _______________

Name: Z. Hamid
Position: Manager

Inzek International Trading B.V. Vissenstraat 32 7324AL – Apeldoorn

info@inzek.nl www.inzek.nl The Netherlands
 Executive Department of Medical
‫ا ﻹ د ا ر ة ا ﻟ ﺘ ﻨ ﻔ ﻴ ﺬ ﻳ ﺔ ﻟ ﺘ ﻘ ﻴ ﻴ ﻢ ا ﻷ ﺟ ﻬﺰ ة ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Devices Evaluation
‫ﻗ ﻄ ﺎ ع ا ﻷ ﺟ ﻬﺰ ة و ا ﻟ ﻤ ﻨ ﺘ ﺠ ﺎ ت ا ﻟ ﻄ ﺒ ﻴ ﺔ‬
Medical Devices And Products Sector

‫ ﻣ ﻨ ﺘ ﺞ ﻃ ﺒ ﻲ‬/ ‫إ ذن ﺗ ﺴ ﻮ ﻳ ﻖ ﺟ ﻬ ﺎز‬
Medical Device Marketing Authorisation

Issuing Date: 18/3/2020 Authorization Number: GHTF-2020-0630 :‫ر ﻗ ﻢ ا ﻹ ذ ن‬ 24/7/1441 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻹ ﺻ ﺪ ا ر‬

Expiry Date: 17/9/2020 Version Number: 1 :‫ر ﻗ ﻢ ا ﻹ ﺻ ﺪ ا ر‬ 30/1/1442 :‫ﺗ ﺎ ر ﻳ ﺦ ا ﻻ ﻧ ﺘ ﻬ ﺎ ء‬

The authorisation is issued in accordance with the Medical ‫أﺻﺪر ﻫﺬا اﻹذن ﺑﻤﻮﺟﺐ ﻻﺋﺤﺔ رﻗﺎﺑﺔ اﻷﺟﻬﺰة واﻟﻤﻨﺘﺠﺎت اﻟﻄﺒ ﻴﺔ واﻟﻘﻮاﻋﺪ‬
devices interim regulation (MDIR) and in particular to the .‫ ( اﻟﺨﺎﺻﺔ ﺑﺈذن ﺗﺴﻮ ﻳﻖ اﻷﺟﻬﺰة واﻟﻤﻨﺘﺠﺎت اﻟﻄﺒ ﻴﺔ‬MDS-IR6 ) ‫اﻻﺟﺮاﺋ ﻴﺔ‬
implementing rule MDS-IR6 for Medical Device Marketing
Authorisation (MDMA)

This authorization allows:

ME0000001235 :‫ﻫﺬا اﻹذن ﻳﺨﻮل‬

Inzek International Trading BV

Vissenstraat 32,Apeldoorn ,Postal Code: 7324 AL Netherlands

To market the medical devices listed in the attached annex* ‫ اﻟﻤﻨﺘﺠﺎت اﻟﻄﺒ ﻴﺔ اﻟﻤﺤﺪدة ﻓﻲ اﻟﻘﺎﺋﻤﺔ اﻟﻤﺮﻓﻘﺔ* ﻓﻲ‬/ ‫ﺑﺘﺴﻮ ﻳﻖ اﻷﺟﻬﺰة‬
in the Kingdom of Saudi Arabia ‫اﻟﻤﻤﻠﻜﺔ اﻟﻌﺮﺑ ﻴﺔ اﻟﺴﻌﻮد ﻳﺔ‬

A rapid test for the qualitative detection of

IgG and IgM antibodies to COVID-19 in
Medical Device Descrip tio n ‫ ا ﻟ ﻤﻨﺘ ﺞ‬/ ‫و ﺻ ﻒ ا ﻟ ﺠ ﻬ ﺎ ز‬
human whole blood, serum or plasma
.specimens

Medical Device Natio nal Listing ‫ ا ﻟ ﻤﻨﺘ ﺞ ا ﻟ ﻄﺒ ﻲ ﻓ ﻲ ا ﻟ ﺴ ﺠ ﻞ‬/ ‫ر ﻗ ﻢ ﻗ ﻴ ﺪ ا ﻟ ﺠ ﻬ ﺎ ز‬

ME0000001235SFDAA00001
Numb er ‫ا ﻟﻮ ﻃﻨ ﻲ‬

COVID-19 IgM/IgM Rapid Test Cassette

Brand / Trade Name ‫ا ﻹ ﺳ ﻢ ا ﻟﺘ ﺠ ﺎ ر ي‬
((Whole Blood/Serum/Plasma

‫اﻟﻤﺪ ﻳﺮ اﻟﺘﻨﻔ ﻴﺬي ﻟﺘﻘ ﻴ ﻴﻢ اﻷﺟﻬﺰة اﻟﻄﺒ ﻴﺔ‬

Executive Director of Medical Devices
Evaluation

‫ﻋﺒﺪ اﻟﻠﻄ ﻴﻒ ﺑﻦ ﺳﻠ ﻴﻤﺎن اﻟﻮﻃﺒﺎن‬.‫د‬

Abdullatif S.Al Watban,Ph.D.

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