Product Classification

• Device: molecular erythrocyte typing test
• Definition: Molecular determination of allelic variants that indicate erythrocyte antigen phenotypes
• Physical State: Solid
• Technical Method: Molecular
• Target Area: DNA
• Review Panel: Hematology
• Product Code: PEP
• Premarket Review: Center for Biologics Evaluation & Research (CBER)
• Submission Type: PMA
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible