Cytocell, Ltd.
FDA 510(k) medical device clearance, cleared in 2018, with 14 FDA device recalls on record.
Top product codes for Cytocell, Ltd.
FDA recalls by Cytocell, Ltd.
10 most recent of 14- Z-2209-2023 — RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
- Z-2210-2023 — RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
- Z-0353-2023 — 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
- Z-0341-2023 — CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
- Z-0824-2022 — Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
- Z-0814-2022 — TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
- Z-0741-2022 — Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH024
- Z-2323-2021 — Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
- Z-2134-2021 — CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
- Z-1493-2021 — Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Cytocell, Ltd.
Data sourced from openFDA. This site is unofficial and independent of the FDA.