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U.S. Department of Health and Human Services

Product Classification

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Device flow cytometry calibrator
Regulation Description Automated differential cell counter.
Definition Flow cytometer calibrators are polystyrene or other particles whose defined characteristics (e.G.Number, size, scatter or fluorescence intensity) is used to standardize instrumentation or to quantify other particles or analytes measured by flow cytometers.
Physical State Beads for performing absolute counts of cells in suspension by flow cytometry Beads for standardizing flow cytometers Beads that are used to calibrate fluorescence intensity to quantify ligand binding or fluorogenic assays performed by flow cytometry Beads that are used to perform calibration in addition to quality control of flow cytometric assays. SHOULD NOT INCLUDE beads that are only used for quality control
Technical Method Bead associated fluorescence or scattered light is used to determine the number of other particles in solution ratio-metrically and to calibrate fluorescence intensity scales on a flow cytometer to standardize measures.
Target Area Peripheral blood
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodePDX
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.5220
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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