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U.S. Department of Health and Human Services

Product Classification

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Device assayed quality control material for clinical microbiology assays
Regulation Description Assayed quality control material for clinical microbiology assays.
Definition Serologic controls for microbiology assays
Physical State Liquid or solid
Technical Method For use with serologic microbiology assays
Target Area Not applicable
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQCH
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3920
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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