“T TULIP DIAGNOSTICS (P) LTD. a PerkinElmer company ear Works: ot Nos. M48 47. Phase 8, Vera dust Estate, Vea, Go 403 722. NDIA To: (882) 8624502 8682000, Fax (0832) 6680186. mal zephy @ulpgroup com SAFETY DATA SHEET CoviRAT ™ Device Page 1 of 8 ‘Section 4: Identification of the substance /mixture and of the company undertaking 4.4 Product identifier : | Product name: CoviRAT ™ Device Product code: 502100025 |1.2 Relevant identified uses of the substance or mixture and uses advised against Use of substancemixture: Rapid, qualitative immunoassay for the detection of nucleocapsid protein antigens expressed by the SARS-CoV-2 virus present in human nasopharyngeal swab specimens. tis to be used for screening or to aid in the diagnosis of COVID-1S disease. This reagent is intended for IN VITRO diagnostic use only. NOT FOR USE IN HUMANS. '1.3 Details of the supplier of the safety data sheet a] Company name: Zephyr Biomedicals, A Division of Tulip Diagnostics (P) Lt. Plot nos. M 46-47, Phase lll B, Verna Industrial Estate, Verna, Goa - 403 722, INDIA www. tulipgroup.com Tel: +91 (0832) 6682000 / 6624502 Fax: (0832) 6680156 Email: tuliparoup com |1-4 Emergency telephone number Emergency tel: +91 (0832) 6682000 / +91 (0832) 6624502 (office hours only) Issue No. 01 Issue date: 17-02-2021 Sign/Date: (QC Dept.) ie porte fx: Ga Tip Bo, vrs Rae ph Bobs Coniox Zephyr Biomedicals Fontes, Gn t8 208 NOMA TEENS, Fc OE) BEE, ADivision of Tulip Diagnostics (P) Ltd. E-mail: sales@itullpgroup com, Website: www tulipgroup.comT TULIP DIAGNOSTICS (P) LTD. a PerkinElmer company ct CO UCASE? Works: Plt Nos. M48 7, Phase, Verna Indust Estate, Vora, Goa 408722, NDIA Tol: (082 8245026682000, Fax (0832) 6680156 Ema zphyr@uiprous.com SAFETY DATA SHEET CoviRAT ™ Device Page 2 of 8 ‘Section 2 : Hazards identification | 2.4 Classification of the substance or mixture Classification under CLP: This product nas no classification under CLP. ‘The product is regulated as an in vitro diagnostic medical device and is not considered hazardous in accordance with regulation (EC) No.1272/2008, 2.2 Label elements Label elements: — None are present. Precautionary statements: P102: Keep out of reach of children 234: Keep only in original container. 2.3 Other hazards: PBT: This product is not identified as a PBT/vPVB substance. Section 3 : Composition /information on ingredients 3.1 Substances "Chemical identit in-io Diagnostic tet for detection of SARS-CoV-2 Antigen in human nasopharyngeal ‘swab specimens. Contains: Contains no hazardous substances in reportable quantities under the CLP. ion 4: First aid measures _ 4.4 Description of first aid measures ‘Skin contact: Wash immediately with plenty of soap and water Eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do so. Continue rinsing. If eye iritation persists, seek medical advicefattention, Ingestion: Do not induce vomnting. Wash mouth with water and give plenty of water to drink immediately. Obtain medical attention if necessary and show label on container. Inhalation: iritation is unlikely to occur but in the event of discomfort, provide plenty of fresh air and if necessary seek medical assistance. issue No.01 — Issue date: 17-02-2021 Sign/Date: (QC Dept.) sonal Corpor Ofer: Gap up Bk 0 Atr oas op, Banoin Consiox Zephyr Biomedicals Pots an 6350 HOT. SE DIT oe OH se ADivision of Tulip Diagnostics (P) Lt. Ennai sales@tulpgroup com, Websie: mn uiparoup com cellence“T TULIP DIAGNOSTICS (P) LTD. a PerkinElmer company See Works: Pt Nos. M48 ~ 4, Phasal 8, Verma Indus Estate, Vera, Gs 408 722 INDIA Tl: (822) 8624502 8642000, Fax (0832) €680186 mal zephyr@ulpgoup cor SAFETY DATA SHEET CoviRAT ™ Device Page 3 of 8 ‘4.2 Most important symptoms and effects, both acute and delayed ‘Skin contact: There may be mild irritation at the site of contact. Eye contact: There may be irritation and redness. Ingestion: There may be iritation of the throat. Inhalation: No symptoms, 433 Indication of any immediate medical attention and special treatment needed __ Immediate / special treatment: Not applicable. ‘Section 6: Fire fighting measures 5.1 Extinguishing media _ Extinguishing media: Suitable extinguishing media such as carbon dioxide, dry chemical powder or polymer foam for the surrounding fire should be used. Use water spray to cool containers, [5.2 Special hazards arising from the substance or mixture Exposure hazards: No known specific hazards 5.3 Advice for fire fighters: Advice for fire-f ighters: Do not enter fire without proper protective equipment, including respiratory protection. |Seotion 6: Accidental release measures 6.4 Personal precautions, protective equipment and emergency procedures 1. Follow Standard Biosafety guidelines during handling of potentially infectious human specimens. 2. Refer to section 8 of SDS for personal protection details. 3. Turn leaking containers leak-side up prevent the escape of liquid. 6.2 Environmental precautions Environmental precautions: Do not discharge into drains or rivers, 8.3 Methods and material for containment and cleaning up Clean-up procedures: For small spills, clean up with paper/cloth, or mop up, and dispose off safely. Clean area of spillage down with plenty of water, Issue No. Of Issue date: 17-02-2021 Sign/Date: (QC Dept) ofc: Gia dp Be AntrDo Roge aah ane Conor Zophyr Biomedicals ou ter, an 03 20 NDI Ta 8) eB fc st) EA Avision of Tl Dagnostes (P) Lid Eat stip on Mats weep“T TULIP DIAGNOSTICS (P) LTD. a PerkinEImer company Works: Pot Nos 48-4, Phase B, Vera dusts Ese, Vara, Goa 408772, NDIA, Tel: (832) 6524502 / 6582000, Fan (082) 6E80156, mal: 2phyr@lulipgoup com SAFETY DATA SHEET CoviRAT ™ Device Page 4 of 8 16.4 Reference to other sections Reference to other sections: Refer to section 8 of SDS ‘Section 7; Handling and storage 7.4 Precautions for safe handling Handling requirements: Refer IFU for CoviRAT™ Device. | 7.2 Conditions for safe storage , including any incompatibilities ‘Storage conditions: Store in original container between 4°C to 30°C . Keep buffer container tightly closed and once opened must be carefully closed back and kept in upright position to prevent leakage, ‘Suitable packaging: Must only be kept in original packaging. ‘end use(s). Specific end use(s): Refer Section 1.2 Exposure controls/personal protection 8.4 Control parameters Workplace exposure limits: Contains no substance with occupational exposure limit values. DNEUIPNEC Values DNEL/ PNEC No dataavailable. 8.2 Exposure controls Engineering measures: Ensure all engineering measures mentioned in section 7 of SDS are in place. Respiratory protection: Respiratory protection not required, Ensure adequate ventilation, Hand protection: Protective gloves. Eye protection: No specific measures are required when using good safe practice Skin protection: Protective clothing not required in normal use. Use proper glove removal technique to avoid skin contact. Issue No. 01 Issue date: 17-02-2021 Sign/Date: (QC Dept.) imma Corporat Ofex ta Tul Block, Dr Ane Do Reo Beh Banbsin Conga Zephyr Biomedicals Post Ofc, Goa- 409.202, NDIA Tel: (0852) 245854651, Fax (832) 2458544. ADWvision of Tulip Diagnestis(P) Lis Esra selesGtuipouncom, West wipgai cam“T TULIP DIAGNOSTICS (P) LTD. a PerkinElmer company a Works: lt Nos. 48 47, Phasal 8, Verma Indus Estate, Vara, as 408 722, INDIA el: (822) 862450 8682000, Fan (0832) €680156 Ema: zephyr@hulpgroup con SAFETY DATA SHEET CoviRAT ™ Device Page 5 of 8 | Section 9: Physical and chemical properties | 9:1 Information on basic physical and chemical properties 1 Device L Extraction Buffer State: Sold guid Colour: White Golouriess dour: Odourless Odourless C ~_ Solubility in water: | Insoluble Not Applicable Viscosity : _ Not Applcabie No data available amg poururangsrce No data available No data available Flash point No data available No deta available er eesen No date available No deta avaiable 7 No data available 75 fading amare: No data avalabie No data available ce No date avaiste No data available | { Saar en No data avaiable 40 9.2 Other Information — ae Other information: No data available. Section 10: Stability and reactivity 10.1 Reactivity 10.2 Chemical stability Reactivity: Stable under recommended transport or storage conditions. ‘Chemical stability: Stable under normal conditions. Issue No.01 Issue date: 17-02-2021 Zephyr Biomedicals ‘AD\ision of Tulip Diagnostic (P) Li Sign/Date: (QC Dept.) Corporat Ofc: Gite, Tul lok. Antonio Do Rego Bagh, Bemba Complex PostOfice, Goa 408202, NDIA Tel: (082) 2458648 1, Fax (832) 2458544, mal seles@hulparoup com, Websie: wn tulpgcupcom“T TULIP DIAGNOSTICS (P) LTD. a PerkinElmer company Works: Plot Nos. 48 47, Phase 8, Vera ndusial Esa, Vara, Goa 408 722, INDIA, Tas (8%) 6524502 6842000, Fax (0832) 680156, mal: 2phy@lulipgoup com SAFETY DATA SHEET CoviRAT ™ Device Page 6 of 8 10.3 Possibility of hazardous reactions Hazardous reactions: Hazardous reactions will not occur under normal transport or storage conditions. 10.4 Conditions to avoid Conditions to avoid: Heat and moisture 10.5 Incompatible materials Materials to avoid: Strong acids /alkalines, oxidising / reducing agents. 40.6 Hazardous decomposition products Hazardous decomposition product 3: No known hazardous decomposition products are formed in high quentties, [Section 11: Toxocological information ‘Section 11.1 Information on Toxocological effects = Toxicity values: No data available. ‘Symptomsiroutes of exposure x - Skin contact: There may be mild iritation at the site of contact Eye contact: There may be irritation and redness. Ingestion: There may be irritation of the throat Inhalation: No symptoms. ‘Section 12: Ecological information (12.4 Toxicity Ecot ity values: No data available. 42.2Persistence and degradability i £ Persistence and degradability: No dataavailable. Issue No. 01 Issue date: 17-02-2021 __SigniDate: (QC Dept) ’ Cupra fice laa, Tle Bc, Anno Do Rego Bap, ant Con Zephyr Biomedicals Fost Gos 5208 NOM Te oA Peo ERO [Divison of Tulip Diagnsts (P) Lia Ema ssGinoin com Wats pac"T TULIP DIAGNOSTICS (P) LTD. a PerkinEImer company ee Works: Pot Nos. 48-47, Phase 8, Verna Indust Este, Vera, Goa 103 72, INDIA Tl: (0H: 8524502 / 6582000, Fax (082) 6680156, Era zphyr@iulipgoup com SAFETY DATA SHEET CoviRAT ™ Device Page 7 of 8 12.3 Bioaccumulative potential Bioaccumulative potenti I: No data available. 12.4 Mobility in soil Mobility: No dataavalable. 12.5 Results of PBT and vPVB assessment PBT identificat : This product is not identified as a PBT/vPvB substance. Other adverse effects Other adverse effec Negligible ecotoxicity. ‘Section 13: Disposal considerations |134_Waste treatment methods _ Disposal operations: Dispose off in accordance with current legislation and local authority regulations as per established safety procedures. NB: The user's attention is drawn to the possible existence of regional or national regulations regarding disposal. Section 14.2 UN proper shipping name pai Asad Shipping name: This product is not covered by international regulation on the transport of dangerous goods (MDG, IATA, ADR/RID) 14,3 Transport hazard class(es) Non -hazardous for transport 14.4 Packing group NIA Tssue No. 07 Issue date: 17-02-2021 Sign/Date {aC Dept , rporte Oe: tne up Sk, Anan Regn ah, ain Care Zephyr Biomedicals oso, #0208 NOT (2855 Fac OH 5 ‘ADivision of Tulip Diagnostics (P) Ltd E-mai:sles@tuipgoupaom, Webi: wnvulipgroup com“T TULIP DIAGNOSTICS (P) LTD. Prsere er SRE CRETE a PerkinElmer company Works: Pot Nos, 48-47, Phasell B, Vera indus Esa, Vara, Goa - 408 722, NDIA “el: (822) 8524502 8682000, Fax (0832) 6680186. mat: zphyr@tulpgroup com SAFETY DATA SHEET CoviRAT ™ Device Page 8 of 8 44.8. Environmental hazards. % 7 Environmentally hazardous : Extraction Buffer contain < 0.1% Sodium Azide. Marine pollutant: No. 44.6 Special precautions for user ‘Special precautions: 1. Shipper boxes should be arranged / stacked in the direction as indicated the shipper label/ Carton. 2. Avoid over-stacking, Do not stack more than & boxes. 3. The reagent in this Extraction Buffer, contains < 0.1% Sodium Azide as a preservative. Sodium Azide has been reported to form Lead or Copper Azide in laboratory plumbing, which may explode on percussion. Flush drains with large volumes of water thoroughly after disposing of fluids containing Sodium Azide. ‘Section 15: Regulatory information 45.1 Safety, health and environmental regulations/legistation specific forthe substance or mixture _ ‘Specific regulations: Applicable national / regional or local regulations. Safe for all kinds of modes of transportation, 15.2 Chemical Safety assessment Not carried out for this product. ‘Section 16: Other informatior Other information: This safety data sheet is prepared in accordance with Commission Regulation (EU) No 453/2010. Legal disclaimer: The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. This company shall not be held liable for any damage resulting from handling or from contact with the above product. Issue No. 01 Issue date: 17-02-2021 _SigniDate: (AC Dept fomath Cones Ofc: lana, Tap Bok Arie Do Rego ah, anton Cae Zephyr Biomedicals Potten Ow 5090 OWT. OA NETES! fac ORR Division of Tulip Diagnostic (P) Ltd, mal sles@tulagcup com Westen tupgreup com