10 results
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11ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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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 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
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