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 | ABBOTT ARCHITECT HBSAG |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | Abbott Laboratories 100 ABBOTT PARK RD. AP5N-2, DEPT. 09VB ABBOTT PARK, IL 60064 |
PMA Number | P060007 |
Supplement Number | S003 |
Date Received | 06/03/2009 |
Decision Date | 06/05/2009 |
Withdrawal Date
|
01/09/2014 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR IMPLEMENTATION OF A NEW QUALITY CONTROL TESTING PROCEDURE WITH A 100-MEMBER PANEL FOR THE ARCHITECT HBSAG REAGENT CONJUGATE. |
|
|