ADVIA CENTAUR ANTI-HBS (AHBS)
FDA premarket approval P030029/S004 · decided 2009-06-10
Approval details
- PMA number
- P030029
- Supplement
- S004
- 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
- 2008-09-18
- Decision date
- 2009-06-10
- Days to decision
- 265 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 BSURFACE 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® AND ADVIACENTAUR® XP ANTI-HBS ASSAY AND IS INDICATED FOR:THE ADVIA CENTAUR ANTI-HBS ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVEAND QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMAN ADULT, AD
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