The new test increases the multiplexing of the sepsis panel from 26 targets to 43 targets, including seven additional resistance genes.
In one of two clearances, Beckman Coulter got the go-ahead to market its Access PCT chemiluminescent immunoassay for measuring levels of procalcitonin.
The firm saw 26 percent growth in molecular biology sales, driven in part by 25 percent sales growth for the BioFire FilmArray product line.
The FDA gave the nod to Shenzhen Bioeasy Biotechnology for two lateral flow immunoassays that provide preliminary results in detecting marijuana in urine.
Roche Diagnostics got the nod for its Elecsys Anti-HAV II test for the detection of total antibodies — IgG and IgM — to the hepatitis A virus.
Clinical applications grew 11 percent driven by 34 percent growth in the molecular biology segment, including a 31 percent spike in FilmArray product sales.
By measuring and analyzing hospital testing operations, the firm anticipates helping its customers implement better antimicrobial stewardship programs.
Included in the 510(k) clearances was one for AMS Diagnostics' Liasys 600 Electrolyte Measurement System for measuring sodium, chloride, and potassium in human serum.
Siemens Healthineers received clearance for its Dimension Exl High-Sensitivity Troponin I Assay used to diagnose acute myocardial infarction.
BioMérieux has increased its stake in Chinese immunoassay developer Hybiome Biomedical Engineering from 54 percent to 67 percent.