Product Classification

• Device: blood grouping reagent
• Regulation Description: Blood Grouping Reagent.
• Definition: For red blood cell antigen typing
• Physical State: Antibody sourced from blood, plasma, serum or immunoglobulin-secreting cells lines
• Technical Method: Antigen and antibody reaction by hemagglutination, column agglutination (gel technique), solid phase adherence or microplate
• Target Area: Red blood cells
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: QHR
• Premarket Review: Center for Biologics Evaluation & Research (CBER)
• Unclassified Reason: Pre-Amendment
• Submission Type: Contact ODE
• Regulation Number: 660.20
• 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