Identity
- Trade Name
- ABBOTT ARCHITECT AUSAB FDA PMA
- Generic Name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays FDA PMA
Identifiers
- PMA Number
- P050051 FDA PMA
- FDA Product Code
- SEI FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3173 FDA PMA
- Regulation Number
- 866.3173 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APRL FDA PMA
The Architect Ausab Reagent Kit is a chemiluminescent microparticle immunoassay (CMIA) designed for the quantitative determination of antibody to hepatitis B surface antigen (anti-HBS) in human serum, plasma (dipotassium EDTA, lithium heparin, and sodium heparin), and neonatal serum. It is classified as a qualitative and quantitative hepatitis B virus antibody assay and is intended for measuring antibody response post-hepatitis B virus (HBV) vaccination, assessing HBV immune status, and aiding in the laboratory diagnosis of HBV disease when used with additional clinical information.
This reagent kit is supplied as part of the Architect i System and requires calibration using the Architect Ausab Calibrators and performance monitoring with the Architect Ausab Controls. The device is intended for use in microbiology laboratories and is approved under an FDA Premarket Approval (PMA). The kit is not validated for use with other anti-HBS assays and is intended for single-use in a regulated clinical setting.
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 | P050051 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Laboratories, Inc.
Sources (1)
- FDA PMA P050051 24 fields · synced Sep 18, 2026