ADVIA CENTAUR ANTI-HBS (AHBS)
FDA premarket approval P030029/S009 · decided 2010-09-01
Approval details
- PMA number
- P030029
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADVIA CENTAUR ANTI-HBS (AHBS)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2009-09-28
- Decision date
- 2010-09-01
- Days to decision
- 338 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR ADDING QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM OR PLASMA TO THE INTENDED USE.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA® CENTAUR ANTI-HBS(AHBS) ASSAY ON CENTAUR CP AND IS INDICATED FOR:ADVIA® CENTAUR ANTI-HBS (AHBS) ASSAY ON THE CENTAUR CP ANALYZER:THE ADVIA CENTAUR ANTI-HBS ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE AND QUANTITATIVE DETERMINATION OF T
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