510(k) clearances for Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
9 on file
- Abbott Molecular, Inc.May 3, 2024
K233349 · Alinity m HSV 1 & 2 / VZV
- Quidel CorporationDec 20, 2023
K232286 · Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
- Diasorin Molecular, LLCNov 26, 2019
K192376 · Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
- ElitechgroupOct 29, 2018
K180559 · HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
- Diasorin Molecular, LLCMar 14, 2018
K173798 · Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
- Quidel CorporationNov 28, 2016
K162451 · Solana HSV 1+2/VZV Assay
- Luminex CorporationOct 6, 2015
K151906 · ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)
- Meridian Bioscience, Inc.Jul 17, 2015
K151046 · illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
- Diagnostic Hybrids, Inc.May 13, 2014
DEN140004 · QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY