Product Classification

• Device: antisera, if, toxoplasma gondii
• Regulation Description: Toxoplasma gondii serological reagents.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: LJK
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.3780
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 7-182 CLSI M36-A
  Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline.

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc