ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS
FDA premarket approval P080023 · decided 2009-04-10
Approval details
- PMA number
- P080023
- Trade name
- ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS
- Generic name
- Qualitative and Quantitative Hepatitis B Virus Antibody assays
- Applicant
- Abbott Laboratories
- Date received
- 2008-08-28
- Decision date
- 2009-04-10
- Days to decision
- 225 days
- Decision code
- APRL
- Product code
- SEI
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR THE ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS. THESE DEVICES ARE INDICATED FOR:ARCHITECT CORE REAGENT KIT: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 DIAGNOSIS OF ACUTE,
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