Data / Medical devices / Qualitative And Quantitative Hepatitis B Virus Antibody Assays
Qualitative And Quantitative Hepatitis B Virus Antibody Assays (SEI): 13 FDA-registered makers in 7 countries
13 establishments in 7 countries are registered with the FDA to make Qualitative And Quantitative Hepatitis B Virus Antibody Assays (product code SEI, Class 2, 21 CFR 866.3173). 12 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on April 7, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- SEI
- Device class
- 2
- Regulation
- 866.3173
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Germany | 2 |
| United Kingdom | 2 |
| Ireland | 2 |
| Italy | 1 |
| France | 1 |
| Spain | 1 |
Makers of Qualitative And Quantitative Hepatitis B Virus Antibody Assays
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 |
|---|---|---|---|---|---|---|---|---|
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 2 | April 7, 2026 | 6 | 0 | 0 | api.fda.gov |
| DiaSorin Italia S.p.A. | SALUGGIA Vercelli, Italy | Manufacturer | 0 | 4 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 4 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Manufacturer | 0 | 4 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Complaint file establishment, Manufacturer, Specification developer | 0 | 4 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 4 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 0 | 4 | 0 | 0 | api.fda.gov | |
| ABBOTT GmbH | Wiesbaden Hesse, Germany | Exporter to the US, Manufacturer | 0 | 3 | 0 | 0 | api.fda.gov | |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Manufacturer | 0 | 3 | 0 | 0 | api.fda.gov | |
| Immunotech SAS, a Beckman Coulter company | MARSEILLE, CEDEX 9 Bouches-du-Rhone, France | Specification developer | 2 | March 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| Abbott Ireland | Sligo, Ireland | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Biokit S.A. | LLISSA D AMUNT Barcelona, Spain | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Beckman Coulter Ireland Inc | O CALLAGHANS MILLS Clare, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 7, 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.