Prothrombin Fragment 1.2

Device Code: 2421

Product Code(s): MIF

Device Classification Information

• Device Type ID: 2421
• Device Name: Prothrombin Fragment 1.2
• Regulation Description: Fibrinogen/fibrin Degradation Products Assay.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 864.7320 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: MIF
• 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: 2421
• Device: Prothrombin Fragment 1.2
• Product Code: MIF
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Fibrinogen/fibrin Degradation Products Assay.
• CFR Regulation Number: 864.7320 [🔎]

Device Problems
Low Test Results	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 20:11:40