Meridian Bioscience Submits Curian Campylobacter Assay to FDA
The test runs on the firm's Curian rapid fluorescent immunoassay and detects four species of a common foodborne pathogen.
Applied Biocode MDx System, GI Pathogen Panel Get FDA 510(k) Clearance
The BioCode GPP tests for 17 of the most common bacteria, viruses, and parasites that cause infectious diarrhea, and runs on the BioCode MDx-3000 system.
The test, based on the next generation of a spinning disk platform, detects three enterotoxins and DNA from three enteric pathogens.
Mobidiag Gets CE Marks for Two Tests
Amplidiag CarbaR+MCR detects the main carbapenemase-producing organisms and colistin resistance markers. Novidiag Bacterial GE+ identifies the most common enteric pathogens.
FDA Clears Two Techlab Campylobacter Tests
The tests detect Campylobacter jejuni and Campylobacter coli and improve upon currently available immunoassays and culture tests, the firm said.