Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | ETI-AB-AUK PLUS |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. STILLWATER, MN 55082-0285 |
PMA Number | P990042 |
Supplement Number | S002 |
Date Received | 01/24/2002 |
Decision Date | 03/05/2002 |
Withdrawal Date
|
10/10/2023 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR INCLUSION OF PLASMA REPRODUCIBILITY STUDIES IN THE PACKAGE INSERT. |
|
|