| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
| |
| Device | ABBOTT AXSYM ANTIBODY TO 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 |
|---|
| Date Received | 07/01/1997 |
|---|
| Decision Date | 02/05/2004 |
|---|
|
Withdrawal Date
|
11/08/2013 |
|---|
| Product Code |
MZO |
| Docket Number | 04M-0207 |
|---|
| Notice Date | 05/05/2004 |
|---|
| Advisory Committee |
Microbiology |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Recalls | CDRH Recalls |
|---|
Approval Order Statement
APPROVAL FOR THE ABBOTT AXSYM ANTIBODY TO HCV. THE DEVICE IS INDICATED FOR THE QUALITATIVE DETECTION OF ANTI-HCV RECOMBINANT PROTEINS IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, SODIUM EDTA, SODIUM HEPARIN, LITHIUM HEPARIN, SODIUM CITRATE, AND POTASSIUM OXALATE). |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
|---|
| Labeling | Labeling
|
|---|
| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
S012 S013 S014 S015 S016 S017 S018 |
|
|
