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 | 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 | S007 |
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 |
Recalls | CDRH Recalls |
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 ANTI-HBC IGM ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE 2000 XPI ANTI-HBC IGM ASSAY AND IS INDICATED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE OR RECENT (USUALLY WITHIN 6 MONTHS) HEPATITIS B VIRUS INFECTIONS IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION. |
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