ADVIA CENTAUR HBC IGM READYPACK REAGENTS AND ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS
FDA premarket approval P030040/S002 · decided 2009-10-20
Approval details
- PMA number
- P030040
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADVIA CENTAUR HBC IGM READYPACK REAGENTS AND ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2008-08-11
- Decision date
- 2009-10-20
- Days to decision
- 435 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR THE TRANSITION OF THE ADVIA CENTAUR HBC IGM ASSAY TO A NEW PLATFORM IN THE CENTAUR FAMILY OF INSTRUMENTS, THE CENTAUR CP. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR HBC IGM ASSAY AND IS INDICATED FOR:ADVIA CENTAUR HBC IGM READYPACK REAGENTS ON THE CENTAUR CP ANALYZER:THE ADVIA CENTAUR HBC IGM ASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVEDETERMINATION OF IGM RESPONSE TO HEPATITIS B VIRUS CORE ANTIGEN IN HUMAN SERUM ANDPLASMA (EDTA OR LITHI
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.