VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
FDA premarket approval P010021/S013 · decided 2008-04-16
Approval details
- PMA number
- P010021
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Date received
- 2008-03-20
- Decision date
- 2008-04-16
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR THE MODIFICATION TO INTERFACE THE AUTOMATED VITROS ANALYZER USING THE ROBOTIC INTERFACE MODULE (RIM) TO ENABLE AUTOMATIC TRAY LOADING BETWEEN THE VITROS ANALYZER AND ENGEN SYSTEM.
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