ADVIA CENTAUR HBC TOTAL ASSAY
FDA premarket approval P040004/S012 · decided 2016-08-11
Approval details
- PMA number
- P040004
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ADVIA CENTAUR HBC TOTAL ASSAY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2015-07-13
- Decision date
- 2016-08-11
- Days to decision
- 395 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- Approval for the migration of the ADVIA Centaur® HBc Total Assay (ADVIA Centaur® HBc Total ReadyPack Reagents and ADVIA Centaur® HBc Total Quality Control Materials) to the ADVIA Centaur® XPT system.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.