|
Device | AMPLICOR HCV TEST, VERSION 2.0 |
Generic Name | Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
Regulation Number | 866.3170 |
Applicant | Roche Molecular Systems, Inc. 4300 HACIENDA DR. PLEASANTON, CA 94588-0900 |
PMA Number | P000010 |
Supplement Number | S010 |
Date Received | 05/24/2007 |
Decision Date | 02/06/2008 |
Withdrawal Date
|
06/30/2014 |
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 A MODIFICATION TO THE TESTING USED TO RELEASE TWO OLIGONUCLEOTIDE INTERMEDIATES FOR FURTHER MANUFACTURE. |