Uridine-5-diphosphoglucose, Nad (u.v.), Alpha-d Galactose-1-phosphate

Device Code: 495

Product Code(s): JLJ

Device Classification Information

• Device Type ID: 495
• Device Name: Uridine-5-diphosphoglucose, Nad (u.v.), Alpha-d Galactose-1-phosphate
• Regulation Description: Galactose-1-phosphate Uridyl Transferase Test System.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 862.1315 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JLJ
• 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: 495
• Device: Uridine-5-diphosphoglucose, Nad (u.v.), Alpha-d Galactose-1-phosphate
• Product Code: JLJ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Galactose-1-phosphate Uridyl Transferase Test System.
• CFR Regulation Number: 862.1315 [🔎]

TPLC Last Update: 2019-04-02 19:35:37