| 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 | IMX(R) HAVAB |
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| Classification Name | hepatitis a test (antibody and igm antibody) |
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| Generic Name | antibody to hepatitis a virus 125i (human) |
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| Regulation Number | 866.3310 |
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| Applicant | ABBOTT LABORATORIES |
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| PMA Number | P780012 |
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| Supplement Number | S005 |
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| Date Received | 04/19/1991 |
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| Decision Date | 10/25/1991 |
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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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