PGI — Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples Class II
Classification Details
- Product Code
- PGI
- Device Class
- Class II
- Regulation Number
- 866.3309
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233349 | abbott molecular | Alinity m HSV 1 & 2 / VZV | May 3, 2024 |
| K232286 | quidel corporation | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument | December 20, 2023 |
| K192376 | diasorin molecular | Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack | November 26, 2019 |
| K180559 | elitechgroup | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius | October 29, 2018 |
| K173798 | diasorin molecular | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | March 14, 2018 |
| K162451 | quidel corporation | Solana HSV 1+2/VZV Assay | November 28, 2016 |
| K151906 | luminex corporation | ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol | October 6, 2015 |
| K151046 | meridian bioscience | illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control | July 17, 2015 |
| DEN140004 | diagnostic hybrids | QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY | May 13, 2014 |