ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS
FDA premarket approval P040004 · decided 2004-12-22
Approval details
- PMA number
- P040004
- Trade name
- ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS
- Generic name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2004-01-30
- Decision date
- 2004-12-22
- Days to decision
- 327 days
- Decision code
- APRL
- Product code
- SEI
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR THE ADVIA CENTAUR HBC TOTAL. HBC TOTAL READYPACK REAGENTS: THE ADVIA CENTAUR HBC TOTAL ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETERMINATION OF TOTAL ANTIBODIES TO THE CORE ANTIGEN OF THE HEPATITIS B VIRUS (HBC TOTAL) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, OR LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR SYSTEM. THIS ASSAY CAN BE USED AS AN AID IN THE DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B VIRUS (HBV) INFECTION AND IN THE DETERMINATIO
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