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Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
FDA product code PGI · Class 2 · Microbiology
14
Registered devices
37
Adverse events
2
Recalls
9
510(k) clearances
Devices with this code
illumigene HSV 1&2 External Control Kit — MERIDIAN BIOSCIENCE, INC.ARIES® HSV 1&2 Assay — LUMINEX CORPORATIONillumigene HSV 1&2 — MERIDIAN BIOSCIENCE, INC.Simplexa™ VZV Swab Direct — DIASORIN MOLECULAR LLCLyra — QUIDEL CORPORATIONAlethia™ HSV 1&2 — MERIDIAN BIOSCIENCE, INC.Alinity m — ABBOTT MOLECULAR INC.Alinity m — ABBOTT MOLECULAR INC.HSV 1&2 ELITe MGB Assay — Elitechgroup Mdx LLCAlinity m — ABBOTT MOLECULAR INC.Alinity m — ABBOTT MOLECULAR INC.Savanna — DIAGNOSTIC HYBRIDS, INC.Alethia™ HSV 1&2 External Control Kit — MERIDIAN BIOSCIENCE, INC.Solana — DIAGNOSTIC HYBRIDS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-05-12 | DiaSorin Molecular LLC | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. |
| 2019-02-20 | Luminex Corporation | Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, re |
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