ClearanceBrief
Company ยท GB

Cytocell Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2025. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (0 in 12 months)
14recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
MVUReagents, Specific, Analyte12
QDIFish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies2
PPMGeneral Purpose Reagent1
SFSRevumenib Eligibility Detection System1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 19, 2025DEN240067KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013)
Cytocell Limited, GB
SFS
Dec 21, 2018DEN170070MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1
Cytocell, Ltd., GB
QDI

Latest recalls

DateFirm and productCodeLinked 510(k)
Jul 20, 2023Cytocell Ltd.
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Open, Classified		 MVUNone listed
Jul 20, 2023Cytocell Ltd.
RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.
Open, Classified		 MVUNone listed
Dec 1, 2022Cytocell Ltd.
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 ch
Terminated		 MVUNone listed
Nov 30, 2022Cytocell Ltd.
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782
Terminated		 MVUNone listed
Feb 14, 2022Cytocell Ltd.
Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
Terminated		 PPMNone listed
Feb 4, 2022Cytocell Ltd.
TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
Terminated		 MVUNone listed
Jan 18, 2022Cytocell Ltd.
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
Terminated		 QDINone listed
May 27, 2021Cytocell Ltd.
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)
Terminated		 MVUNone listed
May 17, 2021Cytocell Ltd.
CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
Terminated		 MVUNone listed
Mar 19, 2021Cytocell Ltd.
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Open, Classified		 MVUNone listed
Dec 22, 2020Cytocell Ltd.
Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 g
Terminated		 MVUNone listed
Jul 17, 2020Cytocell Ltd.
Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151kb probe distal to the NUP98 gene, covering the ZNF195 gene and the D11S4731 mark
Terminated		 MVUNone listed
Jun 19, 2019Cytocell Ltd.
Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including most of the DLEU2 gene, part of the DLEU1 gene and the D13S319
Terminated		 MVUNone listed
Mar 15, 2019Cytocell Ltd.
Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.
Terminated		 MVUNone listed
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