PGI
9 FDA 510(k) clearances · Product code
88 daysmedian time to decision
242 days90th percentile
9clearances measured
FDA profile
- Official device name
- Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3309
- Medical specialty
- Microbiology
- FDA definition
- For the qualitative detection and differentiation of VZV, HSV1, HSV2- DNA in cutaneous and mucocutaneous lesion samples from symptomatic patients. The assay is not intended for use with cerebral spinal fluid.
- Adverse events (MAUDE)
- 2025: 36
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Alinity m HSV 1 & 2 / VZV (K233349) | Abbott Molecular, Inc. | 2024-05-03 |
| Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument (K232286) | Quidel Corporation | 2023-12-20 |
| Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack (K192376) | Diasorin Molecular, LLC | 2019-11-26 |
| HSV 1 & 2 ELITe MGB Kit; ELITe InGenius (K180559) | Elitechgroup | 2018-10-29 |
| Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (K173798) | Diasorin Molecular, LLC | 2018-03-14 |
| Solana HSV 1+2/VZV Assay (K162451) | Quidel Corporation | 2016-11-28 |
| 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) (K151906) | Luminex Corporation | 2015-10-06 |
| illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10 (K151046) | Meridian Bioscience, Inc. | 2015-07-17 |
| QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY (DEN140004) | Diagnostic Hybrids, Inc. | 2014-05-13 |
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Every clearance here is in the API, with alerts when new ones post.