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U.S. Department of Health and Human Services

Product Classification

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Device fungal organisms, nucleic acid-based assay
Definition A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures.
Physical State Reagent Kit
Technical Method Multiplexed nucleic acid-based assay
Target Area N/A
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePEO
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3365
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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