FDA-Device2022-12-07Class II
CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14. Ref: MPD39781
Cytocell Ltd.
Hazard
Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the package insert is incorrect and doesn't not match the probe design or specification contained on the package insert
Sold states
TX
Manufactured in
418 Cambridge Science Park, Milton Road, Oxford Gene Technology, Cambridge, United Kingdom
Products
CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14. Ref: MPD39781
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0353-2023Don't want to check this manually?
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