The U.S. Food and Drug Administration (FDA) announced a flurry of emergency use authorizations (EUAs) for COVID-19 products, including reverse transcription polymerase chain reaction (RT-PCR) tests, ahead of the July Fourth holiday.
Cleared July 2
- U.S. Centers for Disease Control and Prevention (Atlanta): Influenza SARS-CoV-2 Multiplex Assay
Cleared July 1
- Centogene (Cambridge, MA): CentoFast-SARS-CoV-2 RT-PCR Assay
Cleared June 30
- Psomagen (Rockville, MD): Psoma COVID-19 RT Test
- Bio TNS (Honolulu): COVID-19 RT-PCR Peptide Nucleic Acid (PNA) Kit
- InBios International (Seattle): SCoV-2 Detect IgM ELISA
- Kroger (Cincinnati): Kroger Health COVID-19 Test Home Collection Kit, nasal swab specimens
Cleared June 29
- LifeHope Labs (Sandy Springs, GA): LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel
- Acupath Laboratories (Plainview, NY): Acupath COVID-19 Real-Time (RT-PCR) Assay
- Inform Diagnostics (Phoenix): Inform Diagnostics SARS-CoV-2 RT-PCR Assay