Meridian Diagnostics receives all-clear from FDA:
This article was originally published in Clinica
Meridian Diagnostics has received 510(k)clearance from the FDA for two of its enzyme immunoassays Premier Giardia and Premier Cryptosporidium. The tests can detect the presence of the waterborne parasites Giardia and Cryptosporidium in under two hours from a simple stool specimen, according to the Cincinnati-based company. Giardia, which is transmitted through improperly treated water, infects more than two million people in the US every year and Cryptosporidium is particularly harmful in patients with immuno-compromised conditions such as AIDS. The worldwide market for testing of these parasites is estimated at $20 million annually.
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