Fosun COVID-19 RT-PCR Detection Kit
For use under the Emergency Use Authorization (EUA) only

FDA Emergency Use Authorization (EUA) Only
Rx Only
For In Vitro Diagnostic Use.

This test (1) has not been FDA cleared or approved, (2) has been authorized by FDA under an EUA for use by authorized laboratories, (3) has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and (4) is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Covid-19 RT-PCR Detection Kit Targeting Three Genes

The Fosun COVID-19 RT-PCR Detection Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper and lower respiratory specimens (such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate) from individuals suspected of COVID-19 by their healthcare provider. The kit detects ORF1ab, N and the E genes of the SARS-CoV-2 virus. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, to perform high complexity tests.

Resources

Features

3 Targets

ORF1ab, N and E genes

Sample Types*

Including Nasopharyngeal swab, Oropharyngeal swab, Sputum

Amplification Time

1 hour 20 minutes

Controls

Internal control, UNG enzyme and dUTP used to reduce risk of contamination, false positive and false negative results

*Upper and lower respiratory specimens such as anterior nasal swabs, mid-turbinate nasal swabs, nasopharyngeal swabs, oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate or nasal aspirate.

Products

Product NameCatalog NumberPackage Quantity
Fosun COVID-19 RT-PCR Detection KitPCSYHF03-a96 tests/kit

Components

Resources

Product NameCatalog NumberPackage Quantity
Nasopharyngeal SwabFS1001100 packs/Carton (1 per pack)

Features

Resources

For Covid-19 Test Kits and related products Customer Service, please email covid19@fosunpharmausa.com
For Technical Support and Test Verification inquiry, please email inquiry@fosunpharmausa.com
For Medical Device Reporting and Adverse Event, please email medinfo.fosun@apcerls.com or call (866)-611-3762

Manufactured for:
Fosun Pharma USA Inc.
Princeton, NJ 08540
Tel:  (866) 611-8638

Manufactured in China

Last Updated On: May 22, 2020

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Fosun Covid-19 RT-PCR Detection Kit