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510(k)

The test can be used in conjunction with other FDA-cleared Lyme enzyme immunoassays developed by GSD as part of a CDC-recommended modified two-tiered testing algorithm.

Zymo Research previously received CE-IVD marking for the collection device, which enables the transport and storage of SARS-CoV-2 RNA at ambient temperatures.

DiaSorin got the green light for its Liaison Anti-HAV chemiluminescent immunoassay to detect total antibodies to the hepatitis A virus.

The kit helps in the qualitative and semi-quantitative determination of anti-double stranded DNA IgG antibodies with the use of fluorescence microscopy.

The firm said it intends to apply to obtain FDA Emergency Use Authorization and 510(k) clearance for a panel that detects respiratory targets in a single test.

The test was previously cleared by the FDA for use with ethylenediaminetetraacetic acid plasma samples to manage BK virus in transplant patients.

Roche Diagnostics obtained a claim expansion for its Cobas CT/NG assay, which uses real-time PCR to detect Chlamydia trachomatis and Neisseria gonorrhoeae DNA.

The blood test runs on Abbott's i-Stat Alinity platform and returns results within 15 minutes, the company said.

The BioFire Defense subsidiary of BioMérieux obtained clearance for its FilmArray Global Fever Panel External Control Kit, used with the FilmArray Global Fever Panel.

The firm said that the next-generation analyzer has a throughput of 1,200 tests per hour and a large test menu that includes comprehensive panels and specialty tests.

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