ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS, ADVIA CENTAUR HBC TOTAL QUALITY CONTROL
FDA premarket approval P040004/S010 · decided 2015-02-27
Approval details
- PMA number
- P040004
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS, ADVIA CENTAUR HBC TOTAL QUALITY CONTROL
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2014-09-09
- Decision date
- 2015-02-27
- Days to decision
- 171 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR CLAIMS TO TEST NEONATE AND PEDIATRIC POPULATIONS WITH THE FDA APPROVED ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS AND ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS AND ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS AND IS INDICATED FOR:ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMSTHE ADVIA CENTAUR HBC TOTAL ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETERMINAT
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