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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
Order Info Request Form

Components

  • SARS-COV-2 Reaction Reagent
  • RT-PCR Enzyme
  • Positive Control of SARS-CoV-2
  • Negative Control
  • Internal Reference A

Resources

  • Limit of Detection | 300 copies/mL
  • Instrument | Applied Biosystems 7500
  • Storage & Shelf Life | -25° C to -15° C with protection from light, 12 months
  • Symbols Glossary
Product NameCatalog NumberPackage Quantity
Nasopharyngeal SwabFS1001100 packs/Carton (1 per pack)
Order Info Request Form

Features

  • Sterilized by ethylene oxide
  • Nylon Flocking tip
  • Acrylonitrile Butadiene Styrene (ABS) plastic shaft
  • 80mm Breakpoint
  • 3 year Shelf Life

Resources

  • Intended Use | Used for collecting nasopharyngeal specimens, only for in vitro analysis and detection purposes, not for therapeutic use.
  • Transportation | In the process of transportation, protect against heavy load, direct sunlight, rain and snow.
  • Storage & Shelf Life | Store in a clean, cool and dry environment with good ventilation. Avoid corrosive gas, high temperature and high humidity (more than 80% relative humidity). 3 years from date of manufacture
Product NameCatalog NumberPackage Quantity
Fosun Phosphate Buffered SalinePCSYWE-a100 Tubes/Carton
Order Info Request Form

Features

SIZE: 3 mL in 18 x 101 mm Tube

INGREDIENT: Na2HPO4·12H2O, KH2PO4, NaCl and Water

LIMITATIONS: For In Vitro Diagnostic Use. For transport of specimens only. Not to be taken internally.

Resources

  • Intended Use | Single-Use Device. For transport of clinical material and serves as a culture media, non-selective and non-differential.
  • Handling | Handle all specimens as if infectious using safe laboratory procedures. Refer to CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with SARS-CoV-2
  • Storage & Shelf Life | Stable for 12 months while stored at 2°C - 30°C (36°F - 86°F). Store and transport upright at 2°C - 30°C (36°F - 86°F). Please see carton and tube label for expiration date.

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: November 20, 2020

Contact Us

Fosun Pharma USA reversed logo

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.

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Fosun Covid-19 RT-PCR Detection Kit