| 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 MAK-2 PLUS ASSAY |
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| Classification Name | test, hepatitis b (b core, be antigen, be antibody, b core igm) |
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| Generic Name | eia for hepatitis surface ag (hbs ag) |
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| Applicant | DIASORIN, INC. |
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| PMA Number | P990038 |
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| Date Received | 07/02/1999 |
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| Decision Date | 03/30/2001 |
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| Product Code | |
| Docket Number | 01M-0451 |
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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-mak-2 plus assay. The device is indicated for: eti-mak-2 plus is an in vitro enzyme immunoassay (eia) intended for use in the qualitative determination of hepatitis b surface antigen (hbsag) in human serum or plasma (edta, citrate or heparin). The eti-mak-2 plus is intended for manual use and with the biochem immunosystems labotech/eti-lab automated instrument. The detection of hbsag is indicative of a laboratory diagnosis for hepatitis b virus (hbv) infection, either acute or chronic. Further hbv serological marker testing is required to define the specific disease state. The eti-mak-2 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: |
S002 S003 S004 S005 S006 S007
S008 S010 S011 S012 S013 S014
S015 S017 |
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