European Launch of Calprotectin Immunoturbidimetric Assay Announced
ALPCO has launched its FDA-cleared Calprotectin Immunoturbidimetric Assay in Europe and begun a pivotal U.S. clinical trial.
Category: Immunoassay Reagents & test Kits
Immunoassay Reagents & test Kits
Latest
Immunoassay Reagents & test Kits
Latest
Thermo Fisher Gets FDA Clearance for COVID Diagnostic PCR Kit Â
The TaqPath COVID-19 Diagnostic PCR Kit enables labs to adopt a validated in vitro diagnostic workflow for SARS-CoV-2 detection.
Immunoassay Reagents & test Kits
Latest
Sysmex Expands Sale of Reagents for Alzheimer’s Testing to Europe
These reagents, the HISCL β-Amyloid 1-42 and 1-40 assay kits, have attained CE-IVD marking as of May 17, 2022.
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.
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TruDiagnostic and NADMED Partner to Launch Novel NAD+ Blood Test
U.S. Healthcare professionals can access a new novel NAD+ blood diagnostic test for their patients, following the new partnership.
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OncoHost Launches NSCLC Test in the U.S.
OncoHost, a diagnostics company centered on predictive biomarker development patient care, launched its non-small lung cancer (NSCLC) test.
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Beckman Coulter, MeMed Partner on Bacterial and Viral Infection Assay
Beckman Coulter and MeMed are developing a diagnostic assay able to distinguish between bacterial and viral infections.
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Say Goodbye to Equilibrium Dialysis: BioSPME, the Innovative Solution for Clinical Analysis
BioSPME (Bioanalytical Solid Phase MicroExtraction), has been developed to provide a high throughput automatable cleaner sample
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Quest Diagnostics Offers Agilent’s Resolution ctDx FIRST Liquid Biopsy Test
The liquid biopsy ctDx FIRST test is FDA approved as a companion diagnostic for advanced non-small cell lung cancer (NSCLC) patients.
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BD, CerTest Biotec Mpox Test Gets Emergency Use Authorization
BD and CerTest Biotec have announced EUA from the U.S. Food and Drug Administration (FDA) for a molecular PCR assay for Mpox virus detection.
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Dissecting Limitations and Challenges of Mpox Testing
Clinical labs learned about the limitations of mpox testing during last summer’s outbreak, taking away valuable lessons.
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Your Expired COVID Test Kits Might Still Be Good. Here’s How to Find Out
Americans who are still in possession of COVID tests they acquired earlier in the year may wonder whether or not the tests have expired.
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Thermo Fisher’s Monkeypox Test Gets FDA Emergency Use Authorization
The FDA granted Emergency Use Authorization (EUA) for Thermo Fisher Scientific’s Applied Biosystems TaqPath Monkeypox/Orthopox Virus DNA Kit.
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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.
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The Native Antigen Company’s Range of Omicron Antigens Now Includes BA.5 Variant
The Native Antigen Company announced the launch of its latest SARS-CoV-2 antigens for the newly designated omicron BA.5 variant.
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Hologic Gets BARDA Contract to Support IVD Approval of COVID Assays
Funding will bring Hologic’s Panther Fusion SARS-CoV-2/Flu A/B/RSV assay and Aptima SARS-CoV-2 assay in line with the FDA’s IVD standards.
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Monkeypox Diagnostic Testing Launched by US BioTek
US BioTek Laboratories is now offering Monkeypox Diagnostic Testing, utilizing a lesion swap specimen and RT-PCR testing.
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FDA Authorizes Quest Diagnostics’ Monkeypox Test for Emergency Use
Quest Diagnostics received emergency use authorization (EUA) from the U.S. FDA for it’s lab-developed Monkeypox virus test.
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