WebDec 7, 2015 · SUNNYVALE, Calif., Dec. 7, 2015 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the Xpert® Flu+RSV Xpress test for use on the GeneXpert® Xpress™ System. The GeneXpert … WebDec 7, 2015 · The Xpert Flu+RSV Xpress test is the first point-of-care, CLIA-waived assay from Cepheid, and the first waived test on the market to detect and discriminate flu and RSV. The assay runs in about one hour on the company's GeneXpert Xpress system, which is a customized version of the GeneXpert platform consisting of a single module and a …
Cepheid GXIV-2-CLIA - McKesson Medical-Surgical
WebMolecular Diagnostic System GeneXpert® Xpress CLIA Waived. 2-Module System, scalable design. True on-demand, walkaway testing system. Built-in redundancy - each module operates as its own independent anal …. #1043787. Cepheid #GXIV-4-L-RAP. Molecular Diagnostic System GeneXpert® IV. 4 Reaction site. Fully integrated and … WebApr 17, 2024 · modifier to be recognized as a waived test. The CPT code, effective date and description for the latest tests approved by the FDA as waived tests under CLIA are … new way scranton iowa
CLIA Waiver by Application Approval Determination Decision …
WebJul 26, 2024 · SUNNYVALE, Calif., July 26, 2024 /PRNewswire/ -- Cepheid announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the Xpert® Xpress Flu/RSV test. The test can be performed in near-patient settings, providing rapid and … WebRoche has already applied for a CLIA waiver for the cobas Influenza A/B + RSV test. “What we’re really trying to focus on is how we extend this product for the benefit of that ambulatory care segment: primary care, urgent care, the retail clinic setting,” Kane said. Cepheid plans to release the GeneXpert Omni in the United States in late ... WebFeb 23, 2024 · ^CLIA waived tests available for use on the GeneXpert Xpress system. # With early assay termination (EAT) for positive results. Full tests runtimes are as follows: … mike d automotive on watchung avenue