ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
FDA premarket approval P110029 · decided 2012-04-12
Approval details
- PMA number
- P110029
- Trade name
- ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories
- Date received
- 2011-07-26
- Decision date
- 2012-04-12
- Days to decision
- 261 days
- Decision code
- APRL
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR THE ARCHITECT HBSAG QUALITATIVE, ARCHITECT HBSAG QUALITATIVE CONFIRMATORY, ARCHITECT HBSAG QUALITATIVE CONFIRMATORY MANUAL DILUENT, ARCHITECT HBSAG QUALITATIVE CALIBRATORS, AND ARCHITECT HBSAG QUALITATIVE CONTROLS. THIS DEVICE IS INDICATED FOR: ARCHITECT HBSAG QUALITATIVE - THE ARCHITECT HBSAG QUALITATIVE ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) FOR THE QUALITATIVE DETECTION OF HEPATITIS B SURFACE ANTIGEN (HBSAG) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA AND
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