NEW YORK (GenomeWeb News) – Cepheid said today that the US Food and Drug Administration has categorized Cepheid's Xpert MTB/RIF test as "moderate complexity" under CLIA guidelines.
NEW YORK (GenomeWeb News) – Meridian Bioscience said on Monday that its illumigene Group A Streptococcus and illumigene Group B Streptococcus assays have been recategorized by the US Food and Drug Administration as "moderate complexity" tests under the Clinical Laboratory Improv
NEW YORK (GenomeWeb News) – Cepheid today said that the US Food and Drug Administration has categorized the firm's Xpert CT/NG test as moderate complexity under the Clinical Laboratory Improvement Amendments.
NEW YORK (GenomeWeb News) – Nanosphere said after the close of the market Thursday that the US Food and Drug Administration has designated its Gram-Positive Blood Culture nucleic acid test as a moderate-complexity test under CLIA.
With the new rating, the BD Max GBS Assay "will increase access to cost-effective molecular testing for a broad range of laboratories performing GBS screening," BD said.
