VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS
FDA premarket approval P010021/S015 · decided 2009-03-19
Approval details
- PMA number
- P010021
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATORS
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2009-03-06
- Decision date
- 2009-03-19
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- NEW AUTOMATED PROCEDURE FOR CONFIRMING THE VOLUME OF COATING SOLUTION DISPENSED INTO THE MICROTITER WELLS.
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