Container, Specimen, Urine, Drugs Of Abuse, Over The Counter

Device Code: 694

Product Code(s): MPQ

Device Classification Information

• Device Type ID: 694
• Device Name: Container, Specimen, Urine, Drugs Of Abuse, Over The Counter
• Regulation Description: OTC Test Sample Collection Systems For Drugs Of Abuse Testing.
• Regulation Medical Specialty: Pathology
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 864.3260 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: MPQ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 694
• Device: Container, Specimen, Urine, Drugs Of Abuse, Over The Counter
• Product Code: MPQ
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: OTC Test Sample Collection Systems For Drugs Of Abuse Testing.
• CFR Regulation Number: 864.3260 [🔎]

TPLC Last Update: 2019-04-02 19:38:49