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-EBK PLUS |
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 | P990043 |
Supplement Number | S006 |
Date Received | 03/11/2004 |
Decision Date | 03/26/2004 |
Withdrawal Date
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10/10/2023 |
Product Code |
LOM |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE QUALITY CONTROL TEST OF AN INCOMING RAW MATERIAL USED IN THE PREPARATION OF COATED STRIPS OF THE ETI- EBK PLUS WHICH IS AN IN VITRO ENZYME IMMUNOASSAY INTENDED FOR USE IN THE QUALITATIVE DETECTION OF HEPATITIS B E ANTIGEN IN HUMAN SERUM OR PLASMA. |
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