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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
Trade NameABBOTT ANTI-DELTA EIA
Classification Namehepatitis delta serological reagents
Generic Nameanti-delta (ria)
ApplicantABBOTT LABORATORIES
PMA NumberP850062
Supplement NumberS002
Date Received01/21/1997
Decision Date02/26/1997
Product Code
LQI
Advisory Committee Microbiology
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the specifications for the conjugate concentrate from a negative control sample with a standard ration of 0. 90- 1. 10, to a negative control mean o. D. Of 1. 17 - 1. 43.
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