FDA clearance

The infrared spectroscopy-based analyzer is designed to quantitatively measure the concentration of fat, carbohydrate, and protein in human milk.

The test is the second of three panels intended to detect pathogens that cause the bloodstream infections that can lead to sepsis.

The company also received US Food and Drug Administration for its specific immunoglobulin E test for dust mite allergen that runs on the system.

The reagent kit is designed to simplify workflow, improve throughput, and reduce hands-on time and labor costs in performing the T-Spot.TB test.

The guidance addresses cases in which there's enough evidence to conclude that the CDx is suitable for use with a specific group or class of oncology therapies.

The molecular test detects a form of herpes virus that can infect newborns and cause deafness.

The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based test for internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene.

The firm received approval for expanded use of its HIV Combo test, which detects HIV-1 and HIV-2 antibodies and the p24 antigen, on its Vitros ECi/ECiQ Immunodiagnostic System.

The test combines the superior performance of laboratory-based PCR tests and the simplicity and convenience of traditional POC rapid immunoassays, the firm said.

The assay, which was CE marked last month, qualitatively detects group B Streptococcus nucleic acid from 18- to 24-hour Lim broth enrichments.