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 | DIASORIN ETI-AB-COREK 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 | P990045 |
Supplement Number | S005 |
Date Received | 10/20/2003 |
Decision Date | 11/26/2003 |
Withdrawal Date
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10/10/2023 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR EXTENSION OF THE ETI-AB-COREK PLUS ASSAY EXPIRATION DATING FROM 7 MONTHS AND A MINOR LABELING CHANGE IN THE ANALYTICAL SENSITIVITY SECTION OF THE PACKAGE INSERT TO CORRECT A CALCULATION ERROR. |
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