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U.S. Department of Health and Human Services

Product Classification

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Device enzyme linked immunoabsorbent assay, toxoplasma gondii
Regulation Description Toxoplasma gondii serological reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLGD
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
Third Party Review
Accredited Persons
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