|
Device | ELECSYS ANTI-HBS IMMUNOASSAY TEST SYSTEM |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P010054 |
Supplement Number | S005 |
Date Received | 07/11/2006 |
Decision Date | 07/28/2006 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES IN THE QUALITY CONTROL (QC) TESTING PROCEDURE OF RAW MATERIALS FOR CALIBRATORS AND CONTROLS. |