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New Search Back To Search Results Device system, blood culturing Regulation Description Microbial growth monitor. Regulation Medical Specialty Microbiology Review Panel Microbiology Product Code MDB Submission Type 510(k) Regulation Number 866.2560 Device Class 1 GMP Exempt? No Recognized Consensus Standard CLSI M47-A Principles and Procedures for Blood Cultures Guidance Document Review Criteria for Blood Culture Systems   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.