ABBOTT AXSYM ANTI-HCV
FDA premarket approval P970027/S006 · decided 2008-02-22
Approval details
- PMA number
- P970027
- Supplement
- S006
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ABBOTT AXSYM ANTI-HCV
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Abbott Laboratories
- Date received
- 2008-02-11
- Decision date
- 2008-02-22
- Days to decision
- 11 days
- Decision code
- APPR
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR LABELING MODIFICATIONS THAT CORRECT THE ERROR IN THE AXSYM ANTI-HCV PACKAGE INSERT (LIST NUMBER 5C36) UNDER REATENTS SECTION. THE MINIMUM CONCENTRATION OF ?% SOLIDS? FOR THE RECOMBINANT HCV ANTIGEN COATED MICROPARTICLES OF THE AXSYM ANTI-HCV REAGENT PACK IS BEING CHANGED FROM ?0.05%? TO ?0.04%? TO ALIGN WITH CURRENT MANUFACTURING PROCESS.
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