Corab-M Hepatitis B Test
by Abbott Laboratories PMA
Active
PMA P830014
Overview
The Corab-M is a Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen), classified under microbiology diagnostics. It is designed to detect specific antigens associated with Hepatitis B virus infection, including HBsAg, HBeAg, and HBcAg, aiding in the serological diagnosis of the disease.
This device is supplied as a single-use immunoassay kit and requires laboratory processing. It is intended for use in regulated microbiology settings and complies with FDA_PMA authorization (PMA Number: P830014). Sterility and proper storage conditions are critical to maintaining test validity, as outlined in the accompanying instructions.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP830014 | Date3 May 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Corab-M
- Generic Name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- PMA Number
- FDA Product Code
- LOM
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3172
- Advisory Committee
- Microbiology
- FDA Decision
- APPR Approved
- PMA Supplement
- S001
Other devices from Abbott Laboratories
Questions
What specific antigens does the Corab-M test detect, and how does this help in diagnosing Hepatitis B?
The Corab-M detects three key Hepatitis B virus antigens: HBsAg (Hepatitis B surface antigen), HBeAg (Hepatitis B e antigen), and HBcAg (Hepatitis B core antigen). These markers aid in diagnosing infection by identifying active viral replication (HBeAg), exposure to the virus (HBcAg), and the presence of the virus itself (HBsAg), helping clinicians assess infection status, chronicity, and potential contagiousness.
Is the Corab-M kit designed for single-use only, and if so, why is this important for laboratory testing?
Yes, the Corab-M is explicitly a single-use immunoassay kit. This design ensures sterility and prevents cross-contamination between samples, which is critical in microbiology diagnostics to maintain accurate test results and comply with laboratory safety protocols. Reusing components could compromise reliability and introduce errors in Hepatitis B antigen detection.
What storage conditions are necessary to preserve the validity of the Corab-M test, and why does sterility matter here?
The Corab-M requires adherence to the storage conditions outlined in its instructions to maintain sterility and test validity. Since it’s a microbiology diagnostic, contamination or degradation of components could yield false results, leading to incorrect Hepatitis B diagnosis. Proper storage ensures the antigens remain detectable and the kit performs as intended for accurate patient assessment.
How is the Corab-M kit supplied, and what laboratory setup is needed to process it?
The Corab-M is supplied as a single-use immunoassay kit, meaning it comes pre-packaged with all necessary reagents and components for one test run. To process it, a laboratory must have standard microbiology equipment, such as pipettes, centrifuges, and readers compatible with immunoassay techniques, along with trained personnel to follow the manufacturer’s protocols for Hepatitis B antigen detection.