ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIAL
FDA premarket approval P090024 · decided 2011-10-11
Approval details
- PMA number
- P090024
- Trade name
- ADVIA CENTAUR HBEAG ASSAY AND QUALITY CONTROL MATERIAL
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2009-10-22
- Decision date
- 2011-10-11
- Days to decision
- 719 days
- Decision code
- APRL
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- APPROVAL FOR ADVIA CENTAUR HBEAG ASSAY & ADVIA CENTAUR HBEAG QUALITY CONTROL MATERIAL. THIS DEVICE IS INDICATED FOR:ADVIA CENTAUR HBEAG ASSAY:THE ADVIA CENTAUR HBEAG ASSAY IS AN IN-VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF THE HEPATITIS B E ANTIGEN (HBEAG) IN HUMAN SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM OR SODIUM HEPARIN) FROM INDIVIDUALS WHO HAVE SIGNS ANDSYMPTOMS OF HEPATITIS OR WHO MAY BE AT RISK FOR HEPATITIS B VIRUS (HBV) INFECTION USING THE ADVIA CENTAUR AND ADVI
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