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U.S. Department of Health and Human Services

Product Classification

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Device control material, blood circulating epithelial cancer cell
Regulation Description Hematology quality control mixture.
Definition The epithelial cell control kit contains two levels of fixed cells that are stained with a fluorescence marker and are used to verify sample processing and cell analysis of circulating tumor cells.This device is used as an assay quality control to ensure that sample detection and identification systems are able to detect circulating epithelial tumor cells.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeNRS
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.8625
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible