Test, Syphilis, Treponemal

Device Code: 2478

Product Code(s): MTN

Device Classification Information

• Device Type ID: 2478
• Device Name: Test, Syphilis, Treponemal
• Review Panel: Hematology
• Premarket Review: Center For Biologics Evaluation & Research (CBER)
• Submission Type: Contact ODE
• FDA Device Classification: Class Not Classified Medical Device
• Product Code: MTN
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 2478
• Device: Test, Syphilis, Treponemal
• Product Code: MTN

Device Problems
False Negative Result	33
Low Test Results	20
False Positive Result	13
Incorrect Or Inadequate Test Results	5
Low Readings	2
Total Device Problems	73

TPLC Last Update: 2019-04-02 20:13:05