Product Classification

• Device: for export only - antigen, anti-skeletal, indirect fluorescent antibody test system
• Review Panel: Clinical Chemistry
• Product Code: NUL
• Premarket Review: Division of Chemistry and Toxicology Devices (DCTD); Division of Chemistry and Toxicology Devices (DCTD)
• Not Classified Reason: For Export Only
• 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