ADVIA CENTAUR HBSAG READYPACK REAGENTS / CONFIRMATORY ASSAY/ QUALITY CONTROL MATERIAL
FDA premarket approval P030049/S004 · decided 2009-04-09
Approval details
- PMA number
- P030049
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ADVIA CENTAUR HBSAG READYPACK REAGENTS / CONFIRMATORY ASSAY/ QUALITY CONTROL MATERIAL
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2009-03-09
- Decision date
- 2009-04-09
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR ADDING ADVIA CENTAUR XP INSTRUMENT TO THE INTENDED USE OF THEAPPROVED DEVICES ADVIA CENTAUR HBSAG AND ADVIA HBSAG CONFIRMATORY ASSAY. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR HBSAG READYPACKREAGENTS. ADVIA CENTAUR HBSAG READYPACK CONFIRMATORY ASSAY AND ADVIA CENTAUR HBSAGQUALITY CONTROL MATERIAL ARE INDICATED FOR:ADVIA CENTAUR HBSAG READYPACK REAGENTSTHE ADVIA CENTAUR HBSAG ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETECTION
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