Nad-nadh, Specific Reagent For Alcohol Enzyme Method

Device Code: 6090

Product Code(s): DML

Device Classification Information

• Device Type ID: 6090
• Device Name: Nad-nadh, Specific Reagent For Alcohol Enzyme Method
• Regulation Description: Alcohol Test System.
• Regulation Medical Specialty: Toxicology
• Review Panel: Toxicology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 862.3040 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DML
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 6090
• Device: Nad-nadh, Specific Reagent For Alcohol Enzyme Method
• Product Code: DML
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Alcohol Test System.
• CFR Regulation Number: 862.3040 [🔎]

Device Problems
Incorrect Or Inadequate Test Results	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 21:17:09