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
- IMMULITE 2000 XPI ANTI-HBC IMG
- PMA Number
- P010053
- 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
- July 26, 2002
- Date Received
- August 31, 2001
- Expedited Review
- N
- Docket Number
- 03M-0272
Advisory Committee Statement
APPROVAL FOR THE IMMULITE ANTI-HBC IGM AND IMMULITE 2000 ANTI-HBC IGM. THESE DEVICES ARE INDICATED FOR: IMMULITE. ANTI-HBC IGM: IMMULITE ANTI-HBC IGM IS A SOLID-PHASE CHEMILUMINESCENT ENZYME IMMUNOASSAY DESIGNED FOR USE WITH THE IMMULITE AUTOMATED IMMUNOASSAY ANALYZER FOR THE QUALITATIVE MEASUREMENT OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM AND PLASMA (EDTA, HEPARINIZED OR CITRATE). IT IS INTENDED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE OR RECENT (USUALLY WITHIN 6 MONTHS) HEPATITIS B VIRAL INFECTION. IMMULITE. 2000 ANTI-HBC IGM: IMMULITE 2000 ANTI-HBC IGM IS A SOLID-PHASE CHEMILUMINESCENT ENZYME IMMUNOASSAY DESIGNED FOR USE WITH THE IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER FOR THE QUALITATIVE MEASUREMENT IF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN SERUM AND PLASMA (EDTA, HEPARINIZED OR CITRATE). IT IS INTENDED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE OR RECENT (USUALLY WITHIN 6 MONTHS) HEPATITIS B VIRAL INFECTION.
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 |