Plasma, Fibrinogen Control

Device Code: 2282

Product Code(s): GIL

Device Classification Information

• Device Type ID: 2282
• Device Name: Plasma, Fibrinogen 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) Exempt
• CFR Regulation Number: 864.7340 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GIL
• 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

• 7-105 CLSI H30-A2
  Procedure For The Determination Of Fibrinogen In Plasma; Approved Guideline Second Edition

Total Product Life Cycle

• Device Type ID: 2282
• Device: Plasma, Fibrinogen Control
• Product Code: GIL
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Fibrinogen Determination System.
• CFR Regulation Number: 864.7340 [🔎]

TPLC Last Update: 2019-04-02 20:08:52