LIAISON PLEXÂ Gram-Positive Blood Culture Assay Gets 510(k) Nod
Diasorin has received FDA 510(k) clearance for its LIAISON PLEX Gram-Positive Blood Culture Assay, completing its syndromic blood culture portfolio.
Category: Immunoassay Reagents & test Kits
Immunoassay Reagents & test Kits
Latest
Immunoassay Reagents & test Kits
Latest
FDA Clears Werfen Reagents for Enhanced Autoimmune Diagnostics
Werfen's Aptiva APS IgG and IgM Reagents for antiphospholipid syndrome (APS) diagnosis address a need in autoimmune disease diagnostics.
Immunoassay Reagents & test Kits
Latest
Bio-Rad Launches Test Kits for Replication Competent VirusesÂ
Bio-Rad launched the Vericheck ddPCR Replication Competent Lentivirus Kit and the Vericheck ddPCR Replication Competent AAV Kit.Â
OnsiteGene Develops Large Sample-To-Answer PCR Instrument
OnsiteGene has developed a sample-to-answer instrument that is designed to improve PCR testing, the PeakV.
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Absolute Biotech Relaunches SCICONS dsRNA Antibodies and ELISA Kits
Absolute Biotech, a company uniting multiple antibody-centric brands into a single organization, is reintroducing SCICONS dsRNA antibodies.Â
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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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