|
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 | S003 |
Date Received | 04/12/2004 |
Decision Date | 05/06/2004 |
Withdrawal Date
|
06/30/2014 |
Product Code |
MZP |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement INCORPORATION OF A TERMINAL 0.2 UM FILTRATION STEP TO THE AVIDIN-HORSERADISH PEROXIDASE (HRP) BGG CONJUGATE REAGENT MANUFACTURING PROCESS. THE SUBMISSION IDENTIFIED THE CHANGE FOR WHICH THE APPROVAL IS BEING REQUESTED AND PROVIDES THE RATIONALE FOR THE CHANGE. |