Shenzhen Yhlo Biotech Co., Ltd. company News and Trends items

Recently, YHLO iFlash 3000-C Chemiluminescence Analyzer and HCG Test Kit have received FDA 510(k) clearance. It is YHLO’s first 100% independently cleared by FDA. FDA clearance for In Vitro Diagnostic (IVD) products is a crucial regulatory step in the United States. When the FDA clears an IVD product, it means that the product has undergone a thorough evaluation and sign...

The IVDR certificate of YHLO covers additional 58 YHLO chemiluminescent immunoassay (CLIA) detection products including TSH, Cardiolipin IgG, AMH, CA 15-3, CK-MB, HSV-1 IgG etc. Until today, YHLO has obtained IVDR CE Certificate of 72 products, covering the autoimmunity, reproductive health, tumor markers, cardiac markers, infection detection fields and so forth. The Re...

The IVDR certificate of YHLO covers additional 58 YHLO chemiluminescent immunoassay (CLIA) detection products including TSH, Cardiolipin IgG, AMH, CA 15-3, CK-MB, HSV-1 IgG etc. Until today, YHLO has obtained IVDR CE Certificate of 72 products, covering the autoimmunity, reproductive health, tumor markers, cardiac markers, infection detection fields and so forth. The Re...

YHLO Biotech announced today that the iFlash 1800 Chemiluminescence Immunoassay Analyzer and iFlash Total βhCG Assay have received a 510(k) clearance from the U.S. Food and Drug Administration through a local partner. A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent as...

Recently, another installation of YHLO iModules system with Beckman Coulter Power Express clinical lab automation systems was perfectly completed in the Sixth Hospital of Wuhan, Hubei Province, China. This integrated Total Laboratory Automation (TLA) will boost the efficiency of daily workload in the hospital's laboratory.