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FDA okays record number of test kits.


The FDA's Division of Clinical Laboratory Devices approved 38 in vitro diagnostic devices for over-the-counter sale in 1999, according to Laboratory Industry Report (April 2000;8). The agency matched this record once before, in 1996. Sales of home test kits hit approximately $1.8 billion, an increase of more than 10% in 1999, noted Frost & Sullivan in Oakland, CA. This figure excludes blood pressure and temperature monitoring devices.

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Publication:Medical Laboratory Observer
Article Type:Brief Article
Geographic Code:1USA
Date:Jun 1, 2000
Words:68
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