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 | EBK RIA ASSAY/ETI-EBK |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | DIASORIN 1951 NORTHWESTERN AVENUE PO BOX 285 STILLWATER, MN 55082-0285 |
PMA Number | P870048 |
Supplement Number | S008 |
Date Received | 10/05/2000 |
Decision Date | 02/02/2001 |
Withdrawal Date
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09/18/2007 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE NEGATIVE AND POSITIVE CONTROLS AND THE NEUTRALIZING SOLUTIONS FROM DEFIBRINATED PLASMA TO SERUM AND A CHANGE IN THE PURIFICATION PROCESS AND SHELF LIFE OF SOME COMPONENTS OF THE EBK DEVICE AND THE ETI-EBK DEVICE. |
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