510(k)

The firm has completed submissions for all three of its ePlex panels for diagnosis and management of bloodstream infections that can lead to sepsis.

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 detects and distinguishes pertussis and parapertussis in nasopharyngeal swab samples. It is for use on the Quidel's Solana MDx instrument.

It is the first of three ePlex molecular multiplex panels for the diagnosis and management of bloodstream infections that can lead to sepsis.

The firm said that its Cobas CT/NG real-time PCR assay is the first available in the US for the testing of sexually transmitted infections on its 6800 and 8800 systems.

The test is designed to identify a tumor's tissue of origin by assessing 2,000 individual genes and covers 15 common tumor types.

The Xpert Xpress Flu can detect both influenza A and B virus in 20 minutes from either nasopharyngeal or nasal swabs.

The Gastrointestinal Pathogen Panel is the first of a number of planned infectious disease syndromic panels on the firm's PCR-based system. 

The firm's Group A Strep test for use on its Sofia2 analyzer also received CLIA waiver from the agency.