Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | HBSAG |
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 | P010050 |
Supplement Number | S012 |
Date Received | 02/18/2011 |
Decision Date | 05/12/2011 |
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 INTRODUCTION OF A NEW INSTRUMENT MODEL, THE IMMULITE 2000 XPI ANALYZER, AS A NEW FAMILY MEMBER OF THE CURRENTLY APPROVED IMMULITE 2000 ANALYZER, TO BE USED WITH THE CURRENTLY APPROVED IMMULITE 2000 HBSAG ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE 2000 HBSAG ASSAY AN IS INDICATED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE AND CHRONIC HEPATITIS B VIRUS INFECTIONS IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION. |
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