Fosun COVID-19 RT-PCR Detection Kit
For use under the Emergency Use Authorization (EUA) only
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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.
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.
ORF1ab, N and E genes
Including Nasopharyngeal swab, Oropharyngeal swab, Sputum
1 hour 20 minutes
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.
| Product Name | Catalog Number | Package Quantity |
|---|---|---|
| Fosun COVID-19 RT-PCR Detection Kit | PCSYHF03-a | 96 tests/kit |
| Product Name | Catalog Number | Package Quantity |
|---|---|---|
| Nasopharyngeal Swab | FS1001 | 100 packs/Carton (1 per pack) |
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
104 Carnegie Center Drive, Suite 204,
Princeton, NJ 08540
Phone: (866) 611-8638
Contact Customer Service Support at:
Toll Free: (833) 291-9645
Email: GMB-SPS-Fosun@cordlogistics.com
To report an Adverse Event or a Quality complaint,
please contact us at (866) 611-3762
© 2020 Fosun Pharma USA Inc. All rights reserved.