Revogene® SARS-CoV-2 Molecular Assay Receives Re-Authorization from FDA.
Support & Documents
CPT Code 87635
Nasopharyngeal, anterior nasal, mid-turbinate nasal, or oropharyngeal swab specimens collected according to standard technique and placed in 3 mL of transport media according to manufacturer’s instructions.
Swab specimens collected in VTM/UTM can be stored at 2-8 C for up to seven (7) days before being tested with the Revogene SARS-CoV-2 assay. Specimens collected in CDC media, MicroTest™ M4RT® (Remel), or saline may be stored up to 72 hours at 2-8 C before use.
The Revogene SARS-CoV-2 kit can be stored at 2-8 C. The expiration date is indicated on the kit box label. For more information, please refer to the Revogene SARS-CoV-2 package insert.
- This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
- This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
- 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.