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
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PAK/CALIBRATOR
- PMA Number
- P030026
- 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
- March 4, 2004
- Date Received
- June 27, 2003
- Expedited Review
- N
- Docket Number
- 04M-0356
Advisory Committee Statement
APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CALIBRATOR. THESE DEVICES ARE INDICATED FOR: 1) VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK IS INDICATED FOR THE IN VITRO QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (HEPARIN, EDTA AND CITRATE) AND NEONATE SERUM USING THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THE LABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B. 2) VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CALIBRATOR IS INDICATED FOR THE USE IN THE CALIBRATION OF THE VITROS IMMUNODIAGNOSTIC SYSTEM FOR THE IN VITRO QUALITATIVE DETECTION OF IGM ANTIBODY TO HEPATITIS B CORE ANTIGEN (ANTI-HBC IGM) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (EDTA, HEPARIN OR CITRATE) AND NEONATE SERUM USING VITRO ANTI-HBC IGM REAGENT PACKS.
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 |