Home » CEPHEID'S XPERT GBS TEST FOR GROUP B STREPTOCOCCUS RUN ON THE GENEXPERT SYSTEM RECEIVES 510(K) CLEARANCE FROM FDA
CEPHEID'S XPERT GBS TEST FOR GROUP B STREPTOCOCCUS RUN ON THE GENEXPERT SYSTEM RECEIVES 510(K) CLEARANCE FROM FDA
July 31, 2006
Cepheid, a broad-based molecular diagnostics company, announced the 510(k) clearance of its first clinical molecular diagnostic product for the Unites States market. Cepheid received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert GBS test for Group B Streptococcus (GBS) on its GeneXpert platform.
Cepheid (http://phx.corporate-ir.net/phoenix.zhtml?c=122488&p=irol-newsArticle&t=Regular&id=887565&)
KEYWORDS FDAnews Device Daily Bulletin
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