Sekisui OSOM Flu SARS-CoV-2 Combo Control Kit

Description

OSOM Flu SARS-CoV-2 Combo Control Kit is intended for use in external quality control with the OSOM Flu SARS-CoV-2 Combo Antigen Test Kit. For Emergency Use Authorization Only.

• Contains:
  • 5 - Flu A / Flu B / SARS-CoV-2 Positive Control Swab (packaged with a desiccant tablet) coated with non-infectious recombinant influenza A, influenza B, and SARS-CoV-2 containing 0.05% sodium azide
  • 5 Flu A / Flu B / SARS-CoV-2 Negative Control Swabs (packaged with a desiccant tablet) coated with nonviable Group C Streptococci containing 0.09% sodium azide
• Intended for use in external quality control with the OSOM Flu SARS-CoV-2 Combo Antigen Test Kit
• For Emergency Use Authorization Only

Specifications

• Detectable Analytes: SARS-CoV-2, Influenza A and B
• Format: Kit
• For Use With (Equipment): For use in external quality control with the OSOM Flu SARS-CoV-2 Combo Antigen Test Kit
• Sample Type: Swab
• Type: Positive and Negative Lyophilized swab
• Form: Lyophilized

In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens. The emergency use of this product 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.