FDA Clears Thermo Fisher Immunoassay for Neuroendocrine Cancer Patients
Thermo Fisher Scientific announced that the U.S. Food and Drug Administration (FDA) has cleared the Thermo Scientific B·R·A·H·M·S CgA II KRYPTOR immunoassay, a chromogranin A (CgA) test and automated...
View ArticleBio-Rad Launches New PTC Tempo Thermal Cyclers
Bio-Rad Laboratories, a global provider of life science research and clinical diagnostic products, announced the launch of its PTC Tempo 48/48 and PTC Tempo 384 Thermal Cyclers, designed to support...
View ArticleWerfen Gets FDA Clearance for Connective Tissue Disease Essential Reagent
Werfen announced 510(k) clearance of Aptiva Connective Tissue Disease (CTD) Essential reagent by the U.S. Food and Drug Administration (FDA). The Aptiva Connective Tissue Disease Essential reagent...
View ArticleSaladax Biomedical’s FDA-Cleared Clozapine Assay
Saladax Biomedical’s FDA-cleared clozapine assay is designed to provide precise and reliable results in record time, and seeks to redefine the landscape of clozapine therapeutic drug monitoring and...
View ArticleCarolina Liquid Chemistries Offers Microalbumin Reagent for Clinical...
Carolina Liquid Chemistries Corp. has partnered with Kamiya Biomedical Company (Kamiya) to obtain CLIA(1) moderate complexity categorization for K-ASSAY Microalbumin reagent for use on the Medica...
View ArticleSysmex Expands Sale of Reagents for Alzheimer’s Testing to Europe
Sysmex Corp. announces that, following their introduction in Japan and the United States, its reagents used for blood testing to identify Amyloid Beta (Aβ) accumulation in the brain—thought to be a...
View ArticleJanuary/February 2024 Tech Guide: Immunoassay Analyzers
The January/February 2024 Tech Guide that appears in Clinical Lab Products (CLP) features a wide-range of products from top laboratory providers. The 14 providers that took part in the Tech Guide,...
View ArticleWerfen Receives CE Mark for Aptiva Antiphospholipid Syndrome Reagents
Werfen received CE (Conformité Européenne) mark for its Aptiva Antiphospholipid Syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) reagents under the European Union’s (EU) In Vitro...
View ArticleBio-Rad Launches Test Kits for Replication Competent Viruses
Bio-Rad Laboratories, a provider of life science research and clinical diagnostics products, announced the launch of the Vericheck ddPCR Replication Competent Lentivirus Kit and the Vericheck ddPCR...
View ArticleQuidelOrtho’s Triage Placental Growth Factor Test Approved for Labs Canada
QuidelOrtho Corp. received approval from Health Canada for its Triage PLGF test for laboratory use in Canada. The Triage PLGF test is a fluorescence immunoassay to be used with the small footprint...
View Article
