Data / Medical devices / Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples (PGI): 10 FDA-registered makers in 2 countries
10 establishments in 2 countries are registered with the FDA to make Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples (product code PGI, Class 2, 21 CFR 866.3309). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on May 3, 2024, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PGI
- Device class
- 2
- Regulation
- 866.3309
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Italy | 1 |
Makers of Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | Athens, OH, United States | Complaint file establishment, Manufacturer | 3 | December 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Abbott Molecular, Inc. | Des Plaines, IL, United States | Manufacturer, Manufacturer for export | 1 | May 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| DiaSorin Molecular LLC | Cypress, CA, United States | Manufacturer, Manufacturer for export | 1 | November 26, 2019 | 0 | 1 | 0 | api.fda.gov |
| ELITechGroup MDX LLC. | Bothell, WA, United States | Manufacturer | 1 | October 29, 2018 | 0 | 0 | 0 | api.fda.gov |
| ELITechGroup S.p.A. | Torino Piedmont, Italy | Complaint file establishment, Specification developer | 1 | October 29, 2018 | 0 | 0 | 0 | api.fda.gov |
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Manufacturer | 1 | July 17, 2015 | 0 | 0 | 0 | api.fda.gov |
| Quidel Corp. | San Diego, CA, United States | Manufacturer | 1 | December 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Abbott Molecular Distribution Center | Itasca, IL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biogx | Birmingham, AL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epitope Diagnostics, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 3, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.