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CLINIQA Corporation
About CLINIQA Corporation
CLINIQA Corporation is a clinical diagnostics manufacturer with over 40 years of industry experience, specializing in in-vitro diagnostic (IVD) products and biological materials for clinical laboratories. The company manufactures a comprehensive portfolio of quality controls, calibrators, calibration verifiers, and reagents available in liquid, lyophilized, and powder formats. CLINIQA supplies bulk purified proteins, enzymes, disease-state plasmas, infectious disease antigens, and processed serums to diagnostic laboratories globally. The company operates a cGMP-compliant manufacturing facility and offers custom formulation and contract manufacturing services for diagnostic assay development. Product formats feature extended refrigerated stability for liquid preparations. CLINIQA maintains ISO 13485:2016, EN ISO 13485:2016, and MDSAP certifications, demonstrating regulatory compliance across multiple markets. The company employs FDA-compliant, phase-based Design Control processes for product development spanning research through commercial launch. Distribution is supported by a comprehensive network serving diagnostic laboratory customers worldwide.