Test, Thrombin Time

Device Code: 2289

Product Code(s): GJA

Device Classification Information

• Device Type ID: 2289
• Device Name: Test, Thrombin Time
• Regulation Description: Thrombin Time Test.
• 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: 864.7875 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GJA
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 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: 2289
• Device: Test, Thrombin Time
• Product Code: GJA
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Thrombin Time Test.
• CFR Regulation Number: 864.7875 [🔎]

Device Problems
High Test Results	8
Incorrect Or Inadequate Test Results	2
Total Device Problems	10

Recalls
Manufacturer		Recall Class	Date Posted
1	Siemens Healthcare Diagnostics	II	Mar-01-2018

TPLC Last Update: 2019-04-02 20:08:58