Product Classification

• Device: calibrator for alpha-fetoprotein in mid-pregnancy maternal serum
• Review Panel: Immunology
• Product Code: LTQ
• Premarket Review: Division of Immunology and Hematology Devices (DIHD); Division of Immunology and Hematology Devices (DIHD)
• Submission Type: PMA
• Device Class: 3
• 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