Identity
- Trade Name
- AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS FDA PMA
- Generic Name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) FDA PMA
Identifiers
- PMA Number
- P060012 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
The AxSYM Core 2.0 is a microparticle enzyme immunoassay (MEIA) device designed for the qualitative detection of total antibodies (IgG and IgM) to hepatitis B virus core antigen (anti-HBC) in serum or plasma. It aids in diagnosing acute, chronic, or resolved hepatitis B virus (HBV) infection when used alongside other laboratory results and clinical information.
The AxSYM Core 2.0 is intended for use in clinical microbiology laboratories and requires the AxSYM system for operation. It is supplied as a single-use reagent kit, with controls provided for monitoring system performance. The device is FDA-authorized under PMA (P060012) and classified under product code LOM, adhering to regulatory standards for microbiological testing.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF AxSYM CORE - Food and Drug Administration, AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS (P060012) — FDA 510 (k ..., AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS - fda.report, PDF Summary of Safety and Effectiveness Data
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P060012 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Laboratories, Inc.
Sources (1)
- FDA PMA P060012 24 fields · synced Sep 18, 2026