ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/TOTAL QUALITY CONTROL MATERIALS
FDA premarket approval P040004/S004 · decided 2009-04-09
Approval details
- PMA number
- P040004
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS/TOTAL QUALITY CONTROL MATERIALS
- 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 DEVICE ADVIA CENTAUR HBC TOTAL ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR HBC TOTAL ASSAY AND IS INDICATED FOR:THE ADVIA CENTAUR HBC TOTAL ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVEDETERMINATION 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
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