Kit, Test, Alpha-fetoprotein For Neural Tube Defects

Device Code: 3121

Product Code(s): LOK

Device Classification Information

• Device Type ID: 3121
• Device Name: Kit, Test, Alpha-fetoprotein For Neural Tube Defects
• Review Panel: Immunology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: PMA
• FDA Device Classification: Class 3 Medical Device
• Product Code: LOK
• GMP Exempt: No
• Summary MR: Ineligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 3121
• Device: Kit, Test, Alpha-fetoprotein For Neural Tube Defects
• Product Code: LOK
• FDA Device Classification: Class 3 Medical Device

Device Problems
High Test Results	22
Adverse Event Without Identified Device Or Use Problem	10
No Apparent Adverse Event	1
Incorrect, Inadequate Or Imprecise Result Or Readings	1
Incorrect Or Inadequate Test Results	1
Total Device Problems	35

TPLC Last Update: 2019-04-02 20:24:10