ADVIA CENTAUR HBSAG & CONFIRMATORY ASSAYS
FDA premarket approval P030049/S002 · decided 2009-09-25
Approval details
- PMA number
- P030049
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADVIA CENTAUR HBSAG & CONFIRMATORY ASSAYS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2008-07-30
- Decision date
- 2009-09-25
- Days to decision
- 422 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR THE TRANSITION OF THE ADVIA CENTAUR HBSAG ASSAY AND THE ADVIACENTAUR HBSAG CONFIRMATORY ASSAY TO A NEW PLATFORM IN THE CENTAUR FAMILY OF INSTRUMENTS, THECENTAUR CP.ADVIA CENTAUR HBSAG READYPACK REAGENTS ON THE CENTAUR CP ANALYZER:THE ADVIA CENTAUR HBSAG ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR CP SYSTEM.THE ASSAY MA
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