Data / Medical devices / Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) (LOM): 17 FDA-registered makers in 8 countries
17 establishments in 8 countries are registered with the FDA to make Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) (product code LOM, Class 2, 21 CFR 866.3172). 11 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on June 4, 2026, and lists 23 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LOM
- Device class
- 2
- Regulation
- 866.3172
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| United Kingdom | 3 |
| Germany | 2 |
| Ireland | 2 |
| Italy | 1 |
| France | 1 |
| Spain | 1 |
| Japan | 1 |
Makers of Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
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 Italia S.p.A. | SALUGGIA Vercelli, Italy | Manufacturer, Specification developer | 0 | 3 | 0 | 0 | api.fda.gov | |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler | 0 | 3 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 0 | 3 | 1 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Inc. | E Walpole, MA, United States | Manufacturer | 0 | 3 | 2 | 0 | api.fda.gov | |
| ABBOTT GmbH | Wiesbaden Hesse, Germany | Exporter to the US, Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Abbott Ireland | Sligo, Ireland | Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics, Inc. | Rochester, NY, United States | Complaint file establishment, Specification developer | 0 | 2 | 5 | 0 | api.fda.gov | |
| Ortho-Clinical Diagnostics | Pencoed Bridgend, United Kingdom | Manufacturer | 0 | 2 | 1 | 0 | api.fda.gov | |
| DiaSorin Italia S.p.A UK Branch | Dartford Kent, United Kingdom | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Immunotech SAS, a Beckman Coulter company | MARSEILLE, CEDEX 9 Bouches-du-Rhone, France | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Siemens Healthcare Diagnostics Products Limited | LLANBERIS Wales, United Kingdom | Complaint file establishment, Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Bio-Rad Laboratories, Inc. | Woodinville, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biokit S.A. | LLISSA D AMUNT Barcelona, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter Ireland Inc | O CALLAGHANS MILLS Clare, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CTK Biotech, Inc. | Poway, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diagnostic Automation/ Cortez Diagnostics Inc,. | Woodland Hills, CA, United States | Manufacturer, Manufacturer for export, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tosoh Aia, Inc. | Toyama, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 4, 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.