Igm (mu Chain Specific), Antigen, Antiserum, Control

Device Code: 2905

Product Code(s): DAO

Device Classification Information

• Device Type ID: 2905
• Device Name: Igm (mu Chain Specific), Antigen, Antiserum, Control
• Regulation Description: Immunoglobulin (light Chain Specific) 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: 866.5550 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DAO
• 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

• 7-113 CLSI I/LA23-A (Replaces I/LA23-P)
  Assessing The Quality Of Immunoassay Systems: Radioimmunoassays, And Enzyme, Fluorescence, And Luminescence Immunoassays; Approved Guideline

Total Product Life Cycle

• Device Type ID: 2905
• Device: Igm (mu Chain Specific), Antigen, Antiserum, Control
• Product Code: DAO
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Immunoglobulin (light Chain Specific) Immunological Test System.
• CFR Regulation Number: 866.5550 [🔎]

Device Problems
Incorrect Or Inadequate Test Results	2
High Test Results	1
Total Device Problems	3

TPLC Last Update: 2019-04-02 20:20:56