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.
Category: Immunoassay Reagents & test Kits
Immunoassay Reagents & test Kits
Latest
Immunoassay Reagents & test Kits
Latest
PerkinElmer SCID-SMA Kit Gets FDA Authorization
PerkinElmer has announced that the FDA has authorized the marketing of the EONIS SCID-SMA assay kit for the diagnosis of SMA and SCID.
Immunoassay Reagents & test Kits
Latest
MicroGEM & Medline Partner to Equip Healthcare Providers with Saliva Point-of-Care PCR Tests
MicroGEM announced that Medline is now offering the MicroGEM Sal6830 Point of Care PCR System and SARS-CoV-2 Saliva Test.
BD Launches Combo Test for SARS-CoV-2, Influenza & Respiratory Syncytial Virus
The BD MAX Respiratory Viral Panel is a diagnostic combination test for SARS-CoV-2, Influenza A + B and Respiratory Syncytial Virus (RSV).
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Seegene Develops PCR Test to Detect Monkeypox Virus
Seegene, a molecular diagnostics (MDx) company, has developed a PCR test designed to detect the monkeypox virus.
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Co-Diagnostics Completes Principal Design of Monkeypox Virus Test
Co-Diagnostics completed the principal design work of a PCR test for the monkeypox virus, which is exhibiting a multi-country outbreak.
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Seegene Unveils COVID Testing Initiative to Help End Pandemic
Seegene unveiled a global initiative for preemptive and routine PCR COVID-19 testing to help individuals stay healthy during the pandemic.
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LumiraDx Receives WHO Emergency Use Listing for SARS-CoV-2 Ag Test
LumiraDx’s rapid COVID-19 antigen assay, LumiraDx SARS-CoV-2 Ag Test received the Emergency Use Listing by the World Health Organization.
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LumiraDx’s Fast SARS-CoV-2 Ag Ultra Test Achieves CE Marking
Next-generation point-of-care diagnostics company LumiraDx announced that its quick SARS-CoV-2 Ag Ultra Test achieved CE Marking.
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Mologic & Alamar Biosciences Collaborate to Develop a Next-Gen COVID Antigen Test
Alamar and Mologic are collaborating to utilize Alamar’s novel antibodies against SARS-CoV-2 Nucleocapsid protein for future COVID tests.
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Revival Health Medical Supply Awarded Master Distributorship for Boson COVID Test
Revival Health was awarded as the exclusive distributor of Xiamen Boson Biotech’s Rapid SARS-CoV-2 Antigen Tests following a joint agreement.
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D-dimer Immunoassay Validated in Study
HORIBA Medical announces that its novel hemostatic D-dimer immunoassay, Yumizen G DDi 2, has been independently validated.
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Seegene’s New PCR Assay Offers Three-Target Cycle Threshold Value Tech
Molecular diagnostics company Seegene today announced the development of a commercialized PCR assay that applies “3 Ct” technology.
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FDA Grants Quanterix Breakthrough Device Designation for Multiple Sclerosis NfL Test
The NfL plasma test has been granted Breakthrough Device designation as a prognostic aid for patients diagnosed with relapsing-remitting MS.
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New BD Assay Advances Immunology Research Capabilities of Multiomics
BD recently launched a set of reagents designed to enable researchers to more easily analyze important cells in the immune system.
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Pangea Laboratory Donating 50K COVID Tests for the Uninsured
Pangea is donating 50,000 COVID-19 PCR tests, which have been made available for free to the uninsured in Los Angeles and Orange County.
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Nanoparticles Could Enable More Sensitive & Durable Rapid COVID Tests
Researchers have developed a rapid test that uses molecularly imprinted polymer nanoparticles, rather than antibodies, to detect SARS-CoV-2.
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Proof Diagnostics Seeks Emergency Use Authorization of CRISPER-Based POC COVID Test
Proof 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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