Identity
- Trade Name
- AXSYM HBSAG, HBSAG CONFIRMATORY, AND AXSYM HBSAG CONTROLS FDA PMA
- Generic Name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) FDA PMA
Identifiers
- PMA Number
- P050049 FDA PMA
- FDA Product Code
- LOM FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3172 FDA PMA
- Regulation Number
- 866.3172 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APWD FDA PMA
Axsym Hbsag by Abbott Laboratories, Inc. (test, hepatitis b (b antigen, b surface antigen, be antigen)) — Class II — FDA_PMA — listed in FDA PMA
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P050049 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Laboratories, Inc.
Sources (1)
- FDA PMA P050049 24 fields · synced Jun 18, 2026