Product Classification

• Device: quality control for molecular immunohematology tests
• Definition: The quality control for molecular immunohematology assay is used to demonstrate that the test can correctly detect genetic variations of human erythrocyte antigens.
• Physical State: DNA or synthetic plasmids
• Technical Method: Molecular
• Target Area: N/A
• Regulation Medical Specialty: Hematology
• Review Panel: Pathology
• Product Code: PFK
• Premarket Review: CBER Division (CBER)
• Submission Type: 510(k)
• Regulation Number: 864.9650
• Device Class: 2
• 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

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• global quality and regulatory services
• regulatory technology services, llc
• sgs north america