Data / Medical devices / Hepatitis Viral B Dna Detection / United States
FDA-registered makers of Hepatitis Viral B Dna Detection in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Hepatitis Viral B Dna Detection (product code MKT). 4 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Hepatitis Viral B Dna Detection
- Product code
- MKT
- Country
- United States
Makers of Hepatitis Viral B Dna Detection in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Molecular, Inc. | Des Plaines, IL, United States | Manufacturer, Manufacturer for export, Specification developer | 0 | 2 | 2 | 0 | api.fda.gov | |
| Roche Molecular Systems, Inc. | Branchburg, NJ, United States | Manufacturer, Manufacturer for export | 0 | 2 | 1 | 0 | api.fda.gov | |
| Roche Molecular Systems, Inc. | Pleasanton, CA, United States | Specification developer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Hologic, Inc. | San Diego, CA, United States | Manufacturer, Manufacturer for export | 0 | 1 | 0 | 0 | api.fda.gov | |
| Abbott Molecular Distribution Center | Itasca, IL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rpi Biosolutions | Mundelein, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.