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Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
FDA product code QQX · Class 2 · Microbiology
19
Registered devices
1
Adverse events
0
Recalls
11
510(k) clearances
Devices with this code
Simplexa COVID-19 Direct — DIASORIN MOLECULAR LLCBD Respiratory Viral Panel for BD MAX™ System — BECTON, DICKINSON AND COMPANYcobas® SARS-CoV-2 Qualitative 480T — Roche Molecular Systems, Inc.Aptima® — Hologic, Inc.Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer — LIFE TECHNOLOGIES CORPORATIONBioFire® COVID-19 Test 2 — BIOFIRE DEFENSE, LLCAptima® — Hologic, Inc.COVID-19 Coronavirus Real Time PCR Kit — Jiangsu Bioperfectus Technologies Co., Ltd.cobas® SARS-CoV-2 Qualitative 192T — Roche Molecular Systems, Inc.Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control — LIFE TECHNOLOGIES CORPORATIONGeneXpert® — CEPHEIDBD Respiratory Viral Panel-SCV2 for BD MAX™ System — BECTON, DICKINSON AND COMPANYSimplexa COVID-19 Positive Control GEN II Pack — DIASORIN MOLECULAR LLCAptima® — Hologic, Inc.COVID-19 Coronavirus Real Time PCR Kit — Jiangsu Bioperfectus Technologies Co., Ltd.Simplexa COVID-19 Positive Control Pack — DIASORIN MOLECULAR LLCcobas® SARS-CoV-2 Qualitative Control Kit — Roche Molecular Systems, Inc.Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Assay Kit — LIFE TECHNOLOGIES CORPORATIONBioFire® COVID-19 Test 2 — BIOFIRE DEFENSE, LLC
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