ABBOTT ARCHITECT CORE ASSAY
FDA premarket approval P080023/S001 · decided 2009-12-10
Approval details
- PMA number
- P080023
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ABBOTT ARCHITECT CORE ASSAY
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories
- Date received
- 2009-06-19
- Decision date
- 2009-12-10
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR MIGRATION OF THE ARCHITECT® CORE¿ ASSAY TO A NEWARCHITECT® I SYSTEM FAMILY MEMBER, THE ARCHITECT® I 1000SR.THE ARCHITECT CORE REAGENT KIT DEVICE IS INDICATED FOR:THE ARCHITECT CORE ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY(CMIA) FOR THE QUALITATIVE DETECTION OF IGG AND IGM ANTIBODIES TO HEPATITIS B COREANTIGEN (ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (DIPOTASSIUM EDTA, LITHIUM HEPARIN, SODIUM HEPARIN) AND NEONATAL SERUM. IT IS INTENDED AS AN AID IN THE DI
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