FDA Says CLIA Labs Can Use Cepheid's Xpert GBS Test in POC Setting | GenomeWeb
NEW YORK (GenomeWeb News) – The US Food and Drug Administration has said CLIA labs can use Cepheid’s Xpert Group B Streptococcus test, Cepheid said today.
 
Last month the agency cleared the test as an in vitro diagnostic. The recent move, which categorizes the Xpert test as "moderate complexity," means the test can be used by 27,000 additional labs.
 

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