Panels › Microbiology › Product code PGI · Class 2
Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Regulation 866.3309
0510(k)s in 12 months (9 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in PGI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2020 | DiaSorin Molecular LLC MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutan Terminated |
PGI | K192376 |
| Aug 15, 2019 | Luminex Corporation ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295 Open, Classified |
PGI | K151906 K161495 |
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