2,875 results · 49ms · Sources: EU EUDAMED, US FDA

BioFire COVID-19 Test 2

FDA 510(k)
FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert® Xpress CoV-2 plus (XPRS-COV2-10)

FDA 510(k)
FDA Class 2 ·Microbiology

BioFire COVID-19 Test 2

FDA 510(k)
FDA Class 2 ·Microbiology

Aptima SARS-CoV-2 Assay

FDA 510(k)
FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems

FDA 510(k)
FDA Class 2 ·Microbiology

Simplexa COVID-19 Direct

FDA 510(k)
FDA Class 2 ·Microbiology

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit

FDA 510(k)
FDA Class 2 ·Microbiology

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit

FDA 510(k)
FDA Class 2 ·Microbiology

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

FDA 510(k)
FDA Class 2 ·Microbiology

ID NOW Influenza A & B 2

FDA 510(k)
FDA Class 2 ·Microbiology

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,

FDA 510(k)
FDA Class 2 ·Microbiology

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

FDA 510(k)
FDA Class 2 ·Microbiology

CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING

FDA 510(k)
FDA Class 2 ·Microbiology

QUIDEL MOLECULAR INFLUENZA A+B

FDA 510(k)
FDA Class 2 ·Microbiology

Lyra Influenza A+B Assay

FDA 510(k)
FDA Class 2 ·Microbiology

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit

FDA 510(k)
FDA Class 2 ·Microbiology

CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

FDA 510(k)
FDA Class 2 ·Microbiology

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit

FDA 510(k)
FDA Class 2 ·Microbiology

ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2

FDA 510(k)
FDA Class 2 ·Microbiology