510(k) K192376 ยท PGI Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
| Applicant | Diasorin Molecular, LLC, Cypress CA, US |
| Decision | Substantially Equivalent, Nov 26, 2019 |
| Received | Aug 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192376
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.