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Herpes Simplex Virus Nucleic Acid Amplification Assay

FDA product code OQO · Class 2 · Microbiology

16
Registered devices
9
Adverse events
1
Recalls
12
510(k) clearances

Devices with this code

artus® HSV-1/2 QS-RGQ MDx Kit — QIAGEN GmbHSimplexa™ HSV 1 & 2 Positive Control Pack — DIASORIN MOLECULAR LLCAptima® — Hologic, Inc.cobas® 4800 System Lysis Kit — Roche Molecular Systems, Inc.Aptima® — Hologic, Inc.BD ProbeTec™ Herpes Simplex Viruses Assays Reagent Pack — BECTON, DICKINSON AND COMPANYAptima® — Hologic, Inc.Control Set for the BD ProbeTec™ Herpes Simplex Viruses — BECTON, DICKINSON AND COMPANYAptima® — Hologic, Inc.Sentosa SA201 HSV-1/2 PCR Test — VELA OPERATIONS SINGAPORE PTE. LTD.Aptima® — Hologic, Inc.Mutlicode®-RTx HSV 1&2 Kit — LUMINEX CORPORATIONcobas® 4800 System Lysis Kit — Roche Molecular Systems, Inc.cobas® 4800 Systems Internal Control Kit — Roche Molecular Systems, Inc.AmpliVue — QUIDEL CORPORATIONSimplexa™ HSV 1 & 2 Direct — DIASORIN MOLECULAR LLC

Recent recalls

DateFirmReason
2020-05-12DiaSorin Molecular LLCDue to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.

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