ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL
FDA premarket approval P030049 · decided 2005-05-26
Approval details
- PMA number
- P030049
- Trade name
- ADVIA CENTAUR HBSAG READY PACK REAGENTS/CONFIRMATORY READY PACK REAGENTS/QUALITY CONTROL MATERIAL
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2003-11-28
- Decision date
- 2005-05-26
- Days to decision
- 545 days
- Decision code
- APRL
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR THE ADVIA CENTAUR HBSAG READYPACK REAGENTS, ADVIA CENTAUR HBSAG CONFIRMATORY READYPACK REAGENTS, AND ADVIA CENTAUR HBSAG QUALITY CONTROL MATERIAL: ADVIA CENTAUR HBSAG READY PACK INDICATIONS FOR USE: THE ADVIA CENTAUR HBSAG ASSAY IS AN IN VITRO 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 SYSTEM. THE ASSAY MAY BE USED IN CONJUNCTION WITH OTHER SEROLOGI
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