VITROS IMMUNODIAGNOSTIC PRODUCTS HCV REAGENT PACK & CALIBRATOR
FDA premarket approval P010021/S010 · decided 2007-04-16
Approval details
- PMA number
- P010021
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS HCV REAGENT PACK & CALIBRATOR
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2007-03-28
- Decision date
- 2007-04-16
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- ADDITION OF A RAW MATERIAL SUPPLIER FOR UNCOATED MICROWELLS.
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