|
Device | BAYER 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 | S005 |
Date Received | 12/20/2006 |
Decision Date | 08/01/2007 |
Withdrawal Date
|
02/26/2015 |
Product Code |
MZP |
Advisory Committee |
Microbiology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR TRANSFER OF THE MANUFACTURE OF THE WASH REAGENTS (WASH A AND WASH B) TO A CONTRACT MANUFACTURER. THE NUMBER OF BOTTLES PER LOT WILL BE INCREASED FOR BOTH WASH A AND WASH B. |