|
Device | ANTI-HBC IMMULITE SUBSTRATE REAGENT |
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 | P010051 |
Supplement Number | S011 |
Date Received | 12/19/2011 |
Decision Date | 03/27/2012 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO REMOVE THE SLIP AGENT FROM THE BOTTLE USED TO PACKAGE THE IMMULITE SUBSTRATE. |