BEUDAMED
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    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 and D13S272 markers. The 13qter subtelomere specific probe, labelled in green, allows identification of chromosome 13 and acts as a control probe.

    FDA Enforcement
    Class III ·Terminated·Cytocell Ltd.·June 26, 2019

    Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent.

    FDA Enforcement
    Class III ·Terminated·Cytocell Ltd.·May 1, 2019

    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 marker. Fluorescence in situ hybridisation (FISH) is a technique that allows the visualisation of DNA sequences upon chromosomes.

    FDA Enforcement
    Class II ·Terminated·Cytocell Ltd.·August 26, 2020

    Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

    FDA Enforcement
    Class II ·Terminated·Cytocell Ltd.·August 25, 2021

    Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481

    FDA Enforcement
    Class II ·Ongoing·Cytocell Ltd.·May 5, 2021

    RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.

    FDA Enforcement
    Class II ·Ongoing·Cytocell Ltd.·July 26, 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.

    FDA Enforcement
    Class II ·Ongoing·Cytocell Ltd.·July 26, 2023

    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 gene

    FDA Enforcement
    Class II ·Terminated·Cytocell Ltd.·February 17, 2021

    Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008

    FDA Enforcement
    Class III ·Terminated·Cytocell Ltd.·March 30, 2022

    CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics

    FDA Enforcement
    Class II ·Terminated·Cytocell Ltd.·August 4, 2021

    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

    FDA Enforcement
    Class II ·Terminated·Cytocell Ltd.·December 7, 2022

    TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A

    FDA Enforcement
    Class III ·Terminated·Cytocell Ltd.·March 30, 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

    FDA Enforcement
    Class II ·Terminated·Cytocell Ltd.·March 16, 2022

    CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782

    FDA Enforcement
    Class II ·Terminated·Cytocell Ltd.·December 7, 2022

    Sysmex Europe SE

    Importer
    🇩🇪 Germany·7 Manufacturers

    Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's)

    FDA Recall
    Terminated ·Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom·Product code MVU·May 27, 2021

    CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782

    FDA Recall
    Terminated ·Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom·Product code MVU·October 27, 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

    FDA Recall
    Terminated ·Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom·Product code QDI·January 18, 2022

    RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome.

    FDA Recall
    Open, Classified ·Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom·Product code MVU·May 24, 2023

    Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008

    FDA Recall
    Terminated ·Cytocell Ltd. 418 Cambridge Science Park, Milton Road Oxford Gene Technology Cambridge United Kingdom·Product code PPM·February 14, 2022