Whole Human Serum, Antigen, Antiserum, Control

Device Code: 2460

Product Code(s): DGR

Device Classification Information

• Device Type ID: 2460
• Device Name: Whole Human Serum, Antigen, Antiserum, Control
• Regulation Description: Whole Human Plasma Or Serum Immunological Test System.
• Regulation Medical Specialty: Immunology
• Review Panel: Hematology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 866.5700 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: DGR
• 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: 2460
• Device: Whole Human Serum, Antigen, Antiserum, Control
• Product Code: DGR
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Whole Human Plasma Or Serum Immunological Test System.
• CFR Regulation Number: 866.5700 [🔎]

TPLC Last Update: 2019-04-02 20:12:47