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U.S. Department of Health and Human Services

Product Classification

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Device antigens, cf, toxoplasma gondii
Regulation Description Toxoplasma gondiiserological reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeGMN
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3780
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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