Product Classification

• Device: kit, cell screening, fetal
• Review Panel: Pathology
• Product Code: MTI
• Premarket Review: Center for Biologics Evaluation & Research (CBER)
• Not Classified Reason: Unknown
• Submission Type: Contact ODE
• Device Class: Not Classified
• 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