|
Device | VERSANT HCV RNA 3.0 ASSAY (BDNA) |
Generic Name | Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
Regulation Number | 866.3170 |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC. 725 POTTER STREET BERKELEY, CA 94710 |
PMA Number | P020022 |
Supplement Number | S010 |
Date Received | 12/15/2011 |
Decision Date | 12/23/2013 |
Withdrawal Date
|
02/26/2015 |
Product Code |
MZP |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR EXTENSION OF THE SHELF-LIFE OF THE VERSANT HCVRNA 3.0 ASSAY (BDNA) FROM 12 TO 18 MONTHS. |