510(k)

The firm had also applied for marketing clearance for its gram negative and fungal pathogen panels in October.

The enteric panel detects the viral cause of infectious diarrhea symptoms including norovirus, rotavirus, adenovirus, human astrovirus, and sapovirus.

The proposal establishes procedures and criteria for the de novo classification of medical devices that would clarify requirements for submission and review.

The US Food and Drug Administration is developing a new approach for clearing medical devices to take technological advances and modern safety and performance requirements into account.

The agency anticipates that the new pathway will promote comparisons with modern products rather than relying on older predicates.

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.

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Germany's Project DEAL has come to an agreement with the publisher Wiley over journal access and open-access publishing, ScienceInsider reports.

Researchers uncover additional loci associated with lifespan, which the Telegraph says could be folded into a genetic test.

A Canadian panel recommends public coverage of the gene therapy Kymriah if its cost comes down, the Globe and Mail reports.

In Nucleic Acids Research this week: new accurate quantification by sequencing approach, CNV breakpoints in Plasmodium falciparum, and more.