ABBOTT AXSYM ANTIBODY TO HCV
FDA premarket approval P970027 · decided 2004-02-05
Approval details
- PMA number
- P970027
- Trade name
- ABBOTT AXSYM ANTIBODY TO HCV
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Abbott Laboratories
- Date received
- 1997-07-01
- Decision date
- 2004-02-05
- Days to decision
- 2410 days
- Decision code
- APWD
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Abbott Park, IL
- Statement
- APPROVAL FOR THE ABBOTT AXSYM ANTIBODY TO HCV. THE DEVICE IS INDICATED FOR THE QUALITATIVE DETECTION OF ANTI-HCV RECOMBINANT PROTEINS IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, SODIUM EDTA, SODIUM HEPARIN, LITHIUM HEPARIN, SODIUM CITRATE, AND POTASSIUM OXALATE).
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