Test, Albumin Cobalt Binding

Device Code: 635

Product Code(s): NJV

Definition: The Albumin Cobalt Binding Test Is A Quantitative In Vitro Diagnostic Test Used On Human Serum That Detects Ischemia Modified Albumin By Measuring The Cobalt Binding Capacity Of Albumin In Human Serum. IMA Is Intended For Use In Conjunction With Othe

Device Classification Information

• Device Type ID: 635
• Device Name: Test, Albumin Cobalt Binding
• Regulation Description: Creatine Phosphokinase/creatine Kinase Or Isoenzymes Test System.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 862.1215 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NJV
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 635
• Device: Test, Albumin Cobalt Binding
• Product Code: NJV
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Creatine Phosphokinase/creatine Kinase Or Isoenzymes Test System.
• CFR Regulation Number: 862.1215 [🔎]

TPLC Last Update: 2019-04-02 19:37:54