Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control

Device Code: 2242

Product Code(s): DAT

Device Classification Information

• Device Type ID: 2242
• Device Name: Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
• Regulation Description: Fibrinogen Determination System.
• 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: 864.7340 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DAT
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 2242
• Device: Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
• Product Code: DAT
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Fibrinogen Determination System.
• CFR Regulation Number: 864.7340 [🔎]

TPLC Last Update: 2019-04-02 20:08:15