Product Classification

• Device: free radical, benzoylecgnonine
• Regulation Description: Cocaine and cocaine metabolite test system.
• Regulation Medical Specialty: Toxicology
• Review Panel: Toxicology
• Product Code: DNG
• Submission Type: 510(k)
• Regulation Number: 862.3250
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Guidance Document

• Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests - Draft Guidance for Industry and FDA Staff

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.