| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | DIASORIN ETI-CORE-IGMK PLUS ASSAY |
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| Generic Name | eia for igm ab to hepatitis core antigen |
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| Applicant | DIASORIN, INC. |
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| PMA Number | P990044 |
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| Date Received | 07/02/1999 |
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| Decision Date | 03/30/2001 |
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| Docket Number | 01M-0455 |
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| Notice Date | 10/09/2001 |
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| Advisory Committee |
Microbiology |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the diasorin eti-core-igmk plus assay. The device is indicated for: eti-core-igmk plus is an in vitro enzyme immunoassay(eia) intended for use in the qualitative determination of igm antibody to hepatitis b core antigen (igm anti-hbc) in human serum or plasma (edta, citrate or heparin). The eti-core-igmk plus is intended for manual use and with the biochem immunosystems labotech/eti-lab automated instrument. The presence of igm anti-hbc, in the presence of total antibody to hbc (anti-hbc) is indicative of a laboratory diagnosis for acute infection. The absence of igm anti-hbc, in the presence of total anti-hbc, is indicative of a laboratory diagnosis for recovery from hbv infection. Further hbv serological marker testing is required to define the specific disease state. The eti-core-igmk plus assay's performance has not been established for the monitoring of hbv disease or therapy. This assay has not been fda-approved for the screening of blood or plasma donors. |
| Approval Order |
Approval Order
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| Supplements: |
S001 S002 S003 S004 S005 S007
S008 S009 S010 S011 S012 S014
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