Product Classification

• Device: solution, m-nitrophenol, specific reagent for cholinesterase
• Regulation Description: Cholinesterase test system.
• Regulation Medical Specialty: Toxicology
• Review Panel: Toxicology
• Product Code: DMR
• Submission Type: Enforcement Discretion
• Regulation Number: 862.3240
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.