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-AB-AUK 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 | P990042 |
Supplement Number | S011 |
Date Received | 02/17/2012 |
Decision Date | 03/09/2012 |
Withdrawal Date
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10/10/2023 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE QC TEST METHOD USING COMMERCIALLY AVAILABLE ASSAYS FOR THE DETERMINATION OF ANTIBODY ISOTYPE IN RAW MATERIALS, AND THE CHANGE TO ADD MORE STRINGENT ACCEPTANCE CRITERIA FOR SUPPLIER PURCHASED MATERIALS COMMON TO ALL DEVICES. |
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