ARCHITECT AUSAB, ARCHITECT I1000 SYSTEM
FDA premarket approval P050051/S004 · decided 2009-07-23
Approval details
- PMA number
- P050051
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Trade name
- ARCHITECT AUSAB, ARCHITECT I1000 SYSTEM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Abbott Laboratories, Inc.
- Date received
- 2009-02-12
- Decision date
- 2009-07-23
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL TO EXTEND THE APPLICATION OF THE ARCHITECT AUSAB ASSAY, CURRENTLY APPROVED FOR USE ON THE ABBOTT ARCHITECT I2000/ I 2000SR, ONTO A NEW ARCHITECT I SYSTEM FAMILY MEMBER, THE ARCHITECT I 1000SR.ARCHITECT AUSAB REAGENT KIT ON ARCHITECT I 1000SR:THE ARCHITECT AUSAB ASSAY IS A CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY(CMIA) FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIGEN(ANTI-HBS) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (DIPOTASSIUM EDTA, LITHIUMHEPARIN,
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