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Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

FDA product code QWR · Class 2 · Microbiology

5
Registered devices
147
Adverse events
2
Recalls
3
510(k) clearances

Devices with this code

cobas liat SARS-CoV-2 v2 nucleic acid test — Roche Molecular Systems, Inc.cobas SARS-CoV-2 — Roche Molecular Systems, Inc.cobas SARS-CoV-2 Quality Control Kit — Roche Molecular Systems, Inc.ID NOW COVID-19 2.0 — Alere Scarborough, Inc.ID NOW COVID-19 2.0 Control Swab Kit — Alere Scarborough, Inc.

Recent recalls

DateFirmReason
2025-03-04Abbott Diagnostics Scarborough, Inc.the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
2025-03-04Abbott Diagnostics Scarborough, Inc.The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.