|
Device | ELECSYS ANTI-HBS CALCHECK |
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 | S009 |
Date Received | 06/09/2008 |
Decision Date | 07/09/2008 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE INTRODUCTION OF THE ELECSYS ANTI-HBS CALCHECK FOR USE WITH THE ELECSYS ANTI-HBS TEST SYSTEM. THE ELECSYS ANTI-HBS CALCHECK IS USED FOR THE VERIFICATION OF THE CALIBRATION ESTABLISHED WITH THE ELECSYS ANTI-HBS IMMUNOASSAY ON THE ELECSYS 2010 AND MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZERS. THE ELECSYS ANTI-HBS CALCHECK IS NOT A CALIBRATOR. |