|
Device | ABBOTT AXSYM ANTIBODY TO HCV (ANTI-HCV) |
Generic Name | Assay, enzyme linked immunosorbent, hepatitis c virus |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. AP5N-2 DEPT 09VB ABBOTT PARK, IL 60064-3500 |
PMA Number | P970027 |
Supplement Number | S007 |
Date Received | 11/13/2008 |
Decision Date | 07/08/2009 |
Withdrawal Date
|
11/08/2013 |
Product Code |
MZO |
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 A CHANGE IN THE ANTIMICROBIAL FORMULATION TO THE AXSYM ANTI-HCV REAGENT SDB2 (SPECIMEN DILUENT). IN ADDITION, DUE TO THE REFORMULATION OF THE SDB2, THE INSTRUCTION TO USE STERILE WATER FOR TUBING DECONTAMINATION IS NO LONGER A REQUIRED PROCEDURE AND CAN BE REMOVED FROM THE PACKAGE INSERT LABELING. |