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New Search Back To Search Results Device radioimmunoassay, human chorionic gonadotropin Regulation Description Human chorionic gonadotropin (HCG) test system. Regulation Medical Specialty Clinical Chemistry Review Panel Clinical Chemistry Product Code JHI Submission Type 510(k) Regulation Number 862.1155 Device Class 2 GMP Exempt? No Recognized Consensus Standard CLSI/NCCLS GP14-A 1996 Labeling of Home-Use In Vitro Testing Products; Approved Guideline Guidance Document Review Criteria for Assessment of Professional Use Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVDs)   Third Party Review Eligible for Accredited Persons Program Accredited Persons british standards institution center for measurement standards of industrial cheiroon bv citech intertek testing services regulatory technology services, llc tuv rheinland of north america, inc. tuv sud america inc. underwriters laboratories, inc.