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 | IMMULITE / IMMULITE 1000 HBSAG ASSAY AND IMMULITE 2000 HBSAG ASSAY |
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 | S008 |
Date Received | 05/13/2009 |
Decision Date | 06/02/2009 |
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 REVISIONS TO THE PRODUCT LABELING TO INCLUDE A ¿HOT ZONE CUTOFF¿ UNDER THE INTERPRETATION OF RESULTS SECTION. THIS ¿HOT ZONE CUTOFF¿ ESTABLISHES A LEVEL AT WHICH HIGH HBSAG REACTIVE SAMPLES MAY BE REPORTED AS REACTIVE WITHOUT CONFIRMATORY TESTING. |
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