| 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-AB-EBK PLUS ASSAY |
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| Generic Name | eia for antibody to hepatitis be antigen |
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| Applicant | DIASORIN, INC. |
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| PMA Number | P990041 |
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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-0452 |
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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-ab-ebk plus assay. The device is indicated for: eti-ab-ebk plus is an in vitro enzyme immunoassay (eia) intended for use in the qualitative detection of total antibodies to hepatitis b e antigen (anti-hbe) in human serum or plasma (edta, citrate or heparin). The eti-ab-ebk plus is intended for manual use and with the biochem immunosystems labotech/eti-lab automated instrument. The detection of anti-hbe is indicative of laboratory diagnosis for seroconversion and progression to hepatitis b virus (hbv) clearance. A reactive test is presumptive laboratory evidence of hbv seroconversion. Further hbv serological marker testing is required to define the specific disease state. The anti-hbe assay's performance has not been established for the monitoring of hbv disease or therapy. |
| Approval Order |
Approval Order
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| Supplements: |
S001 S002 S003 S004 S005 S006
S008 S009 S010 S011 S012 S013
S014 S016 |
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