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 | ETI-MAK-2 PLUS ASSAY |
Generic Name | Test, hepatitis b (b core, be antigen, be antibody, b core igm) |
Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. STILLWATER, MN 55082-0285 |
PMA Number | P990038 |
Supplement Number | S012 |
Date Received | 11/13/2009 |
Decision Date | 01/12/2010 |
Withdrawal Date
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10/10/2023 |
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 A CHANGE IN THE SAMPLE STABILITY CLAIM FOR 48 HOURS AT 2-8 DEGREES C TO 8 DAYS AT 2-8 DEGREES C AND MODIFICATIONS OF THE LABELING TO REFLECT THE CHANGE. |
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