Identity
- Trade Name
- AXSYM CORE-M 2.0 AND AXSYM CORE-M 2.0 CONTROLS FDA PMA
- Generic Name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) FDA PMA
Identifiers
- PMA Number
- P060009 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-M 2.0 is a microparticle enzyme immunoassay (MEIA) intended for the in vitro qualitative detection of IgM antibody to hepatitis B virus core antigen (IgM anti-HBC) in serum or plasma. This assay aids in diagnosing acute or recent hepatitis B virus (HBV) infection when used alongside other laboratory results and clinical information.
The Axsym Core-M 2.0 is supplied as a reagent pack for use with the Axsym system and is intended for single-use in clinical microbiology laboratories. It requires no special storage conditions beyond those specified in the accompanying instructions and is regulated under FDA Premarket Approval (PMA P060009). Controls for the Axsym Core-M 2.0 are provided to monitor system performance when using the specified reagent pack.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P060009 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Laboratories, Inc.
Sources (1)
- FDA PMA P060009 24 fields · synced Sep 18, 2026