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U.S. Department of Health and Human Services

Product Classification

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Device assayed external control material for microbiology nucleic acid amplification (nat) assays
Regulation Description Assayed quality control material for clinical microbiology assays.
Definition Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.
Physical State solid or liquid
Technical Method For use with nucleic acid amplification microbiology assays
Target Area Not applicable - Single or multi-analyte
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePMN
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons