Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
Basic Information
- Device Name
- Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
- Trade Name
- ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIAL
- PMA Number
- P090024
- Device Class
- FDA Class 3
- Product Code
- LOM
- Generic Name
- Test, hepatitis b (b core, be antigen, be antibody, b core igm)
- Medical Specialty
- Unknown
- Advisory Committee
- Microbiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 11, 2011
- Date Received
- October 22, 2009
- Expedited Review
- N
- Docket Number
- 11M-0737
Advisory Committee Statement
APPROVAL FOR ADVIA CENTAUR HBEAG ASSAY & ADVIA CENTAUR HBEAG QUALITY CONTROL MATERIAL. THIS DEVICE IS INDICATED FOR:ADVIA CENTAUR HBEAG ASSAY:THE ADVIA CENTAUR HBEAG ASSAY IS AN IN-VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF THE HEPATITIS B E ANTIGEN (HBEAG) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARIN) FROM INDIVIDUALS WHO HAVE SIGNS ANDSYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B VIRUS (HBV) INFECTION USING THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THIS ASSAY, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, IS INTENDED ONLY FOR THE DETERMINATION OF CHRONIC INFECTION WITH HEPATITIS B VIRUS.ADVIA CENTAUR HBEAG QUALITY CONTROL MATERIAL:THE CONTROLS ARE USED FOR MONITORING THE PERFORMANCE OF THE HBEAG ASSAY ON THE ADVIA CENTAUR SYSTEMS. THE PERFORMANCE OF THE HBEAG QUALITY CONTROL MATERIAL HAS NOT BEEN ESTABLISHED WITH ANY OTHER HBEAG ASSAY.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | FDA class 3 | Unknown |