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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...