T2Biothreat Panel FDA 510(k) Submission Announced
T2 Biosystems, Inc.,has submitted a 510(k) premarket notification to the FDA for the Company’s T2Biothreat Panel.
T2 Biosystems, Inc.,has submitted a 510(k) premarket notification to the FDA for the Company’s T2Biothreat Panel.
PerkinElmer has announced that the FDA has authorized the marketing of the EONIS SCID-SMA assay kit for the diagnosis of SMA and SCID.
MicroGEM announced that Medline is now offering the MicroGEM Sal6830 Point of Care PCR System and SARS-CoV-2 Saliva Test.
The BD MAX Respiratory Viral Panel is a diagnostic combination test for SARS-CoV-2, Influenza A + B and Respiratory Syncytial Virus (RSV).
Read MoreSeegene, a molecular diagnostics (MDx) company, has developed a PCR test designed to detect the monkeypox virus.
Read MoreCo-Diagnostics completed the principal design work of a PCR test for the monkeypox virus, which is exhibiting a multi-country outbreak.
Read MoreSeegene unveiled a global initiative for preemptive and routine PCR COVID-19 testing to help individuals stay healthy during the pandemic.
Read MoreLumiraDx’s rapid COVID-19 antigen assay, LumiraDx SARS-CoV-2 Ag Test received the Emergency Use Listing by the World Health Organization.
Read MoreNext-generation point-of-care diagnostics company LumiraDx announced that its quick SARS-CoV-2 Ag Ultra Test achieved CE Marking.
Read MoreAlamar and Mologic are collaborating to utilize Alamar’s novel antibodies against SARS-CoV-2 Nucleocapsid protein for future COVID tests.
Read MoreRevival Health was awarded as the exclusive distributor of Xiamen Boson Biotech’s Rapid SARS-CoV-2 Antigen Tests following a joint agreement.
Read MoreHORIBA Medical announces that its novel hemostatic D-dimer immunoassay, Yumizen G DDi 2, has been independently validated.
Read MoreMolecular diagnostics company Seegene today announced the development of a commercialized PCR assay that applies “3 Ct” technology.
Read MoreThe NfL plasma test has been granted Breakthrough Device designation as a prognostic aid for patients diagnosed with relapsing-remitting MS.
Read MoreBD recently launched a set of reagents designed to enable researchers to more easily analyze important cells in the immune system.
Read MorePangea is donating 50,000 COVID-19 PCR tests, which have been made available for free to the uninsured in Los Angeles and Orange County.
Read MoreResearchers have developed a rapid test that uses molecularly imprinted polymer nanoparticles, rather than antibodies, to detect SARS-CoV-2.
Read MoreProof Diagnostics announced the submission of its EUA request for review to the U.S. FDA for its POC molecular diagnostic test for COVID-19.
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