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New Search Back To Search Results Device radioimmunoassay, testosterones and dihydrotestosterone Regulation Description Testosterone test system. Regulation Medical Specialty Clinical Chemistry Review Panel Clinical Chemistry Product Code CDZ Submission Type 510(k) Regulation Number 862.1680 Device Class 1 GMP Exempt? No 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.