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U.S. Department of Health and Human Services

Product Classification

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Device antisera, if, toxoplasma gondii
Regulation Description Toxoplasma gondii serological reagents.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeLJK
Premarket Review Division of Microbiology Devices (DMD)
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
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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