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MSDS-0284 MSDS For COVID-19 Rapid Test

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杭州博拓生物科技股份有限公司 Hangzhou Biotest Biotech Co., Ltd. 文件编号 Document No.

:MSDS-0284
MSDS for COVID-19 Rapid Test 第 1页共 3 页 Page 1 of 3

MSDS for COVID-19 Rapid Test

I .1.Indentification of the product


Product Name: COVID-19 Rapid Test
Brand: RightSign®

I .2.Use of the preparation


The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid
chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to
SARS-CoV-2 in human whole blood, serum, or plasma as an aid in the diagnosis of
primary and secondary COVID-19 infections.

I .3.Company Indentifiation
Company: Hangzhou Biotest Biotech Co., Ltd.
Address: #17 Futai Road, Zhongtai Street , Yuhang District , Hangzhou. P.R.China.
311121
Tel: 0086-571-89058016
Fax:0086-571-88633388
E-mail: info@biotests.com.cn
I .4.Emergency telephone No.
Emergency telephone: 0086-571-89058016

II Information of Ingredients
Sodium Azide Concentration: = <0.02% (7.5ng/test)
CAS#: 26628-22-8

III Hazards Indentification


Not dangerous preparation

IV First aid measures


First-aid personnel: N/A
After inhalation: N/A
After skin contact: N/A
After eye contact: N/A
After swallowing: N/A

V. Fire-fighting measures
Inflammable in contact with flames, not explosive.
Extinguishing media: water or foam

VI Accidental release measure


N/A
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杭州博拓生物科技股份有限公司 Hangzhou Biotest Biotech Co., Ltd. 文件编号 Document No.:MSDS-0284
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VII. 1. Handling
Good Laboratory Practices(disposal gloves)

VII. 2. Storage
Store in a dry place at +2℃ to +30℃
Avoid storage near to heat sources
Accessible only for authorized persons

VIII. Exposure controls/personal protection


Specimen collection and preparation : all the specimens should be considered potentially
hazardous and handled in the same manner as an infectious agent.
Use disposal gloves.

IX. Physical and chemical properties


Form: Solid reaction strip that could be placed into a plastic cassette depending on the
format used.
Colour: White solid with red lines.
Odour: N/A
pH value: N/A
Melting point: N/A
Ignition temperature: N/A
Flash point: N/A
Explosion limits: N/A
Density: N/A

X. Stability and reactivity


1. Stable
2. Conditions to be avoided: Strong heating, direct contact with flames.
3. Substances to be avoided: only use provided diluent for sample dilution

XI. Toxicological information


N/A

XII. Ecological information


The COVID-19 Rapid Test should be discarded in a proper biohazard container after
testing.

XIII. Disposal considerations


After testing, the COVID-19 Rapid Test must be disposed of compliance with the
respective national regulations.

XIV. Transport information


Not dangerous preparations, not required transport regulation.
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杭州博拓生物科技股份有限公司 Hangzhou Biotest Biotech Co., Ltd. 文件编号 Document No.:MSDS-0284
MSDS for COVID-19 Rapid Test 第 3页共 3 页 Page 3 of 3

XV. Regulatory information


This product does not require special labeling, in accordance with the appropriate EC
directives.

This product is for in vitro diagnostic use therefore must compile with the European
Directive 98/79/EC bearing the CE label prior to the placing on the market.

XVI. Other information


For professional in vitro Diagnostic use only. Consult instructions for use.

References:
1. REGULATION (EC) No 1907/2006
2. REGULATION (EC) No 1272/2008
3. IVDD 98/79/EC
4. World Health Organization (WHO). WHO Statement Regarding Cluster of Pneumonia
Cases in Wuhan, China. Beijing: WHO; 9 Jan 2020.
5. Weiss SR, Leibowitz JL. Coronavirus pathogenesis. Adv Virus Res 2011;81:85-164.
6. Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol 2019;
17:181-192.
7. Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of
coronaviruses. TrendsMicrobiol 2016;24:490-502.

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