Strip, Hama Igg, Elisa, In Vitro Test System

Device Code: 3044

Product Code(s): MLH

Device Classification Information

• Device Type ID: 3044
• Device Name: Strip, Hama Igg, Elisa, In Vitro Test System
• 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: MLH
• 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: 3044
• Device: Strip, Hama Igg, Elisa, In Vitro Test System
• Product Code: MLH
• 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 20:23:01