Fosun-Pharma-USA-Brand-2022
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.

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.

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.

Products

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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

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. 

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Features

MODEL: MNP-96C

COMPONENTS: MNP Lysis-binding Buffer, MNP Magnetic Beads, MNP Washing Buffer I, MNP Washing Buffer II, MNP Elution Buffer
*Note: Plates provided in this kit are single-use only. Do not reuse the plates

LIMITATIONS: This product is only suitable for upper respiratory tract specimens (including oral swabs, throat swabs, nasal swabs and nasopharyngeal extracts) and lower respiratory tract specimens (including bronchoalveolar lavage fluid and alveolar lavage fluid); performance for other types of samples or samples in other preservation buffers cannot be guaranteed.

Instructions for Use

  • Intended Use | This kit with reagents for 96 isolations was designed for the isolation DNA/RNA from upper respiratory tract specimens (including oral swabs, throat swabs, nasal swabs and nasopharyngeal extracts), lower respiratory tract specimens (including bronchoalveolar lavage fluid and alveolar lavage fluid). For Pr For Professional Use Only. For In Vitro Diagnostic Use.
  • Storage & Shelf Life | Stable for 12 months from date of manufacture while stored at room temperature 10°C - 30°C (50°F - 86°F). Please see label for expiration date.
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Features

MODEL: MNP-100F

COMPONENTS: MNP Lysis-binding Buffer, MNP Magnetic Beads, MNP Washing Buffer I, MNP Washing Buffer II, MNP Elution Buffer.
Note: The components in different batches of reagents can be used interchangeably within the validity period.

LIMITATIONS:

This product is only suitable for upper respiratory tract specimens (including oral swabs, throat swabs, nasal swabs and nasopharyngeal extracts) and lower respiratory tract specimens (including bronchoalveolar lavage fluid and alveolar lavage fluid); performance for other types of samples or samples in other preservation buffers cannot be guaranteed.

Instructions for Use (IFU)

  • Intended Use | This kit with reagents for 100 isolations was designed for the isolation DNA/RNA from upper respiratory tract specimens (including oral swabs, throat swabs, nasal swabs, nasopharyngeal extracts), lower respiratory tract specimens (including bronchoalveolar lavage fluid, alveolar lavage fluid). For Professional Use Only
  • Storage & Shelf Life | Stable for 12 months from date of manufacture while stored at room temperature 10°C - 30°C (50°F - 86°F). Please see 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: September 8, 2021

104 Carnegie Center Drive, Suite 204
Princeton, NJ 08540
(609) 250-2802

info.usa@fosunpharma.com
Customer Service: (833) 291-9645
Adverse Event/ Quality Concern: (866) 611-376202

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Fosun Covid-19 RT-PCR Detection Kit