|
Device | ADVIA CENTAUR HBSAG AND HBSAG CONFIRMATORY ASSAYS |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 333 CONEY STREET WALPOLE, MA 02032-1516 |
PMA Number | P030049 |
Supplement Number | S010 |
Date Received | 03/26/2012 |
Decision Date | 10/15/2012 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT STRATEC BIOMEDICAL SWITZERLAND AG IN BERINGEN, SWITZERLAND. |