Method, Immunodiffusion, Immunoglobulins (g, A, M)

Device Code: 2875

Product Code(s): CGM

Device Classification Information

• Device Type ID: 2875
• Device Name: Method, Immunodiffusion, Immunoglobulins (g, A, M)
• Regulation Description: Immunoglobulins A, G, M, D, And E Immunological Test System.
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 866.5510 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: CGM
• 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

Total Product Life Cycle

• Device Type ID: 2875
• Device: Method, Immunodiffusion, Immunoglobulins (g, A, M)
• Product Code: CGM
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Immunoglobulins A, G, M, D, And E Immunological Test System.
• CFR Regulation Number: 866.5510 [🔎]

TPLC Last Update: 2019-04-02 20:20:27