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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