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-EBK PLUS KIT |
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 | P990041 |
Supplement Number | S010 |
Date Received | 01/29/2009 |
Decision Date | 02/25/2009 |
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 APPROVAL TO MOVE THE MANUFACTURING OF THE RECOMBINANT HBEAG FROM A SUPPLIER TO INSIDE DIASORIN AND TO REVISE THE QC PROCEDURE FOR PURIFIED R-HBE AG RAW MATERIAL ACCEPTANCE. |
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