ADVIA CENTAUR HCV ON CENTAUR CP
FDA premarket approval P030056/S002 · decided 2009-08-13
Approval details
- PMA number
- P030056
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADVIA CENTAUR HCV ON CENTAUR CP
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2008-08-25
- Decision date
- 2009-08-13
- Days to decision
- 353 days
- Decision code
- APPR
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR THE TRANSITION OF THE ADVIA CENTAUR HCV ASSAY TO A NEW PLATFORM IN THE CENTAUR FAMILY OF INSTRUMENTS, THE CENTAUR CP.ADVIA CENTAUR HCV READYPACK REAGENTS ON THE CENTAUR CP ANALYZERTHE ADVIA CENTAUR HCV ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVEDETERMINATION OF IMMUNOGLOBULIN G (IGG) ANTIBODIES TO HEPATITIS C VIRUS (HCV) IN HUMAN SERUM AND PLASMA (EDTA, LITHIUM OR SODIUM HEPARINIZED) USING THE ADVIA CENTAUR CP SYSTEM. THE ASSAY MAY BE USED IN CONJUNCTION WITH OTH
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