Data / Medical devices / Herpes Simplex Virus Nucleic Acid Amplification Assay
Herpes Simplex Virus Nucleic Acid Amplification Assay (OQO): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Herpes Simplex Virus Nucleic Acid Amplification Assay (product code OQO, Class 2, 21 CFR 866.3305). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on February 1, 2018, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OQO
- Device class
- 2
- Regulation
- 866.3305
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Switzerland | 1 |
| Singapore | 1 |
Makers of Herpes Simplex Virus Nucleic Acid Amplification Assay
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 |
|---|---|---|---|---|---|---|---|---|
| DiaSorin Molecular LLC | Cypress, CA, United States | Manufacturer | 1 | August 28, 2015 | 0 | 1 | 0 | api.fda.gov |
| Hologic, Inc. | San Diego, CA, United States | Manufacturer | 1 | June 15, 2017 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics International Ltd. | ROTKREUZ Zug, Switzerland | Manufacturer | 1 | June 1, 2015 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | Manufacturer | 1 | June 1, 2015 | 0 | 0 | 0 | api.fda.gov |
| Roche Molecular Systems, Inc. | Pleasanton, CA, United States | Specification developer | 1 | June 1, 2015 | 0 | 0 | 0 | api.fda.gov |
| Vela Operations Singapore Pte Ltd | Singapore Central Singapore, Singapore | Complaint file establishment, Manufacturer | 1 | February 1, 2018 | 0 | 0 | 0 | api.fda.gov |
Updated February 1, 2018. 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.