Product Classification

• Device: anti-human globulin
• Regulation Description: Anti-Human Globulin.
• Definition: For the performance of direct and indirect antiglobulin tests in blood banking/ immunohematology
• Physical State: Sourced from either serum from animals immunized with one or more human serum globulins or from stable immunoglobulin secreting cell lines
• Technical Method: Antigen and Antibody Reaction by hemagglutination, Column Agglutination (gel technique), solid phase or microplate
• Target Area: Red blood cells, serum, plasma
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: QHS
• Premarket Review: Center for Biologics Evaluation & Research (CBER)
• Unclassified Reason: Pre-Amendment
• Submission Type: Contact ODE
• Regulation Number: 660.50
• Device Class: Unclassified
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible