ADVIA CENTAUR HCV READYPACKS
FDA premarket approval P030056/S008 · decided 2015-03-10
Approval details
- PMA number
- P030056
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ADVIA CENTAUR HCV READYPACKS
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2014-09-15
- Decision date
- 2015-03-10
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR THE CLAIM TO TEST A PEDIATRIC POPULATION WITH THE FDA APPROVED ADVIA CENTAUR HCV READYPACK REAGENTS AND ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ADVIA CENTAUR HCV READYPACK REAGENTS AND ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS AND IS INDICATED FOR:ADVIA CENTAUR AND ADVIA CENTAUR XP SYSTEMS. THE ADVIA CENTAUR HCV (AHCV) ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE QUALITATIVE DETERMINATION OF IMMUNOGLOBULIN G
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