| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS |
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| Classification Name | hepatitis a test (antibody and igm antibody) |
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| Regulation Number | 866.3310 |
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| Applicant | DIASORIN, INC. |
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| PMA Number | P890019 |
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| Supplement Number | S005 |
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| Date Received | 11/24/1997 |
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| Decision Date | 09/22/1998 |
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| Product Code | |
| Advisory Committee |
Microbiology |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | change design/components/specifications - other |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for a change in the enzyme tracer and tracer diluent from an igg (human) anti-hav-hrp to a fab anti-hav (mab)-hrp; a change in the positive control and negative control materials to human source sera; the elimination of the mercury preservative in the reagents; and the addition of a neutralizing solution, incubation buffer and a calibrator reagent. The device, as modified, will be marketed under the trade name diasorin eti-ab-havk plus and is intended for the qualitative determination of total antiboides to hepatitis a virus (anti-hav) in human serum or plasma. This assay is indicated for use as an aid in the dignosis of current or previous hepatitis a virus infection and as an aid in the diagnosis of current or previous hepatitis a virus infection and as an aid in the identification of hav-susceptible individuals for vaccination. |
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