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Article: Infectio Diagnostic -I.D.I.- Inc. Submits Premarket Notification 510k to FDA and Health Canada for its IDI-Strep B Test.
- Article from:
- Business Wire
- Article date:
- August 16, 2002
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Business Editors & Health/Medical Writers
BIOWIRE2K
QUEBEC CITY, Quebec--(BW HealthWire)--Aug. 16, 2002
Infectio Diagnostic (I.D.I.) Inc., in partnership with Cepheid (Sunnyvale, CA), announced today it has filed a premarket notification (510(k)) in order to obtain FDA and Health Canada clearances of IDI-Strep B(TM), its first PCR-based test for the rapid screening of Group B Streptococcus (GBS) in pregnant women at the time of delivery.
The IDI-Strep B(TM) test is performed directly from a vagino-rectal swab on Cepheid's Smart Cycler(TM) instrument. IDI's test will enable physicians to obtain the result in less than 1 hour after the ...