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New Search Back To Search Results Device blood, occult, colorimetric, in urine Regulation Description Occult blood test. Regulation Medical Specialty Hematology Review Panel Hematology Product Code JIO Submission Type 510(k) Regulation Number 864.6550 Device Class 2 GMP Exempt? No Recognized Consensus Standard CLSI/NCCLS GP14-A 1996 Labeling of Home-Use In Vitro Testing Products; Approved Guideline Third Party Review Eligible for Accredited Persons Program Accredited Persons british standards institution cheiroon bv citech intertek testing services regulatory technology services, llc tuv rheinland of north america, inc. tuv sud america inc. underwriters laboratories, inc.