DeviceClearance

Product code NRS— Hematology

CELLSEARCH EPITHELIAL CELL CONTROL KIT

Classification name
Control Material, Blood Circulating Epithelial Cancer Cell
Device class
Class 2
Regulation
21 CFR 864.8625
Advisory panel
Hematology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code NRS under 21 CFR 864.8625, via openFDA

Market context for product code NRS

FDA has cleared 1 device under product code NRS, all in 2004, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NRS

Recent clearances under product code NRS

Data sourced from openFDA. This site is unofficial and independent of the FDA.