|
Device | IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | Siemens Healthcare Diagnostics Products, LTD GLYN RHONWY LLANBERIS, CAERNARFON LL55 |
PMA Number | P010053 |
Supplement Number | S003 |
Date Received | 08/17/2005 |
Decision Date | 11/02/2005 |
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 CHANGES IN THE MANUFACTURING PROCESS WHICH ADD AN INCOMING RAW MATERIAL TEST. |