CLIA denotes chemiluminescence immunoassay, ELISA enzyme-linked immunosorbent assay, HIT heparin-induced thrombocytopenia, MGTS monoclonal gammopathy of thrombotic significance, OD optical density ...
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Roche’s STI assay panels gain FDA 510(k) clearance and CLIA waiverRoche has received 510(k) clearance with a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver from the US Food and Drug Administration (FDA) for its cobas liat sexually transmitted ...
"CLIA registration represents a significant step forward for ... Specializing in genomic, proteomic, immunoassay, and cell-based assay solutions, the company serves biopharmaceutical innovators with ...
Roche announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat sexually transmitted ...
The company’s CLIA-certified lab in Irvine ... “One of the key components of the test is a protease turnover assay for an enzyme that is atypically found in the pancreas, thus providing biological ...
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