Product Classification

• Device: reagent red blood cells
• Regulation Description: Reagent Red Blood Cells.
• Definition: For the detection of or identification of human blood-group antibodies
• Physical State: Sourced from human blood
• Technical Method: Antigen and antibody reaction by hemagglutination, column agglutination (gel technique), solid phase or microplate
• Target Area: Serum or plasma
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: QHT
• Premarket Review: Center for Biologics Evaluation & Research (CBER)
• Unclassified Reason: Pre-Amendment
• Submission Type: Contact ODE
• Regulation Number: 660.30
• 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