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 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 | S007 |
Date Received | 12/02/2008 |
Decision Date | 02/09/2009 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REPLACEMENT OF THE SODIUM BASED BUFFER WITH POTASSIUM PHOSPHATEBUFFER AND ADDITION OF 2.0% NORMAL MOUSE SERUM AND 1.2% E-AMINO-N-CAPROIC ACID IN REAGENT A,AND THE ADDITION OF 0.2% SODIUM HEPARIN IN REAGENT B FOLLOWED BY REFILTERING OF DILUENT, AND ISINDICATED FOR IN VITRO DIAGNOSTIC USE FOR THE LABORATORY DIAGNOSIS OF ACUTE AND CHRONIC HEPATITIS BVIRUS INFECTIONS IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION. |
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