ADVIA CENTAUR HBC IGM READYPACK REAGENTS/QUALITY CONTROL MATERIALS
FDA premarket approval P030040/S004 · decided 2009-04-09
Approval details
- PMA number
- P030040
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ADVIA CENTAUR HBC IGM READYPACK REAGENTS/QUALITY CONTROL MATERIALS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2009-03-09
- Decision date
- 2009-04-09
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR ADDING ADVIA CENTAUR XP INSTRUMENT TO THE INTENDED USE OF THE APPROVED DEVICE ADVIA CENTAUR HBC IGM ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETEDUNDER THE TRADE NAME ADVIA CENTAUR HBC IGM ASSAY AND IS INDICATED FOR: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 LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR AND ADVIACENTAUR XP SYSTEMS. THE A
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