Product Classification

• Device: alpha-2-macroglobulin, fitc, antigen, antiserum, control
• Regulation Description: Alpha-2-macroglobulin immunological test system.
• Regulation Medical Specialty: Immunology
• Review Panel: Immunology
• Product Code: DDY
• Submission Type: 510(k)
• Regulation Number: 866.5620
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.