ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL
FDA premarket approval P100039 · decided 2012-01-20
Approval details
- PMA number
- P100039
- Trade name
- ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND QAULITY CONTROL MATERIAL
- Generic name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2010-08-17
- Decision date
- 2012-01-20
- Days to decision
- 521 days
- Decision code
- APRL
- Product code
- SEI
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- APPROVAL FOR ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY AND ADVIA CENTAUR ANTI-HBS2 (AHBS2) QUALITY CONTROL MATERIAL FOR USE ON THE ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THIS DEVICE IS INDICATED FOR: ADVIA CENTAUR ANTI-HBS2 (AHBS2) ASSAY, THE ADVIA CENTAUR ANTI-HB2 ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE AND QUANTITATIVE DETERMINATION OF TOTAL ANTIBODIES TO HEPATITIS B SURFACE ANTIGEN IN HUMAN ADULT, ADOLESCENT, AND PEDIATRIC SERUM OF PLASMA (EDTA, LITHIUM-HEPARINIZED, O
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