Plasma, Control, Normal

Device Code: 2288

Product Code(s): GIZ

Device Classification Information

• Device Type ID: 2288
• Device Name: Plasma, Control, Normal
• Regulation Description: Multipurpose System For In Vitro Coagulation Studies.
• 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: 864.5425 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GIZ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-101 CLSI H51-A
  Assays Of VonWillebrand Factor Antigen And Ristocetin Cofactor Activity; Approved Guideline.
• 7-159 CLSI H21-A5
  Collection, Transport, And Processing Of Blood Specimens For Testing Plasma-Based Coagulation Assays And Molecular Hemostasis Assays

Total Product Life Cycle

• Device Type ID: 2288
• Device: Plasma, Control, Normal
• Product Code: GIZ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Multipurpose System For In Vitro Coagulation Studies.
• CFR Regulation Number: 864.5425 [🔎]

TPLC Last Update: 2019-04-02 20:08:57