ARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT
FDA premarket approval P060007 · decided 2006-09-07
Approval details
- PMA number
- P060007
- Trade name
- ARCHITECT HBSAG REAGENT KIT, CALIBRATORS, CONTROLS, CONFIRMATORY REAGENT KIT, CONFIRMATORY MANUAL DILUENT
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories
- Date received
- 2006-02-24
- Decision date
- 2006-09-07
- Days to decision
- 195 days
- Decision code
- APWD
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR THE ARCHITECT HBSAG REAGENTS, ARCHITECT HBSAG CALIBRATORS, ARCHITECT HBSAG CONTROLS, ARCHITECT HBSAG CONFIRMATORY REAGENTS, AND ARCHITECT HBSAG CONFIRMATORY MANUAL DILUENT. THE ARCHITECT HBSAG 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 (DIPOTASSIUM EDTA). THE ASSAY MAY ALSO BE USED TO SCREEN FOR HBV INFECTION IN PREGNANT FEMALES TO IDENTIFY NEONATES WH
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