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CytoCell® IVDR probes

In 1991, CytoCell® became the first provider of FISH probes in the world. Over 30 years later, they are still pioneering the FISH frontiers and are the first to market with In Vitro Diagnostic Regulation (IVDR) certified FISH Probes!

Switching to IVDR-certified FISH probes means you can be confident that your laboratory is using safe, reliable and effective tools for diagnosing patients.

CytoCell® IVDR FISH probes remain the same trusted products with the extra IVDR seal — the unquestionable testament to our commitment to provide innovative, class-leading products under this substantially more stringent regulation. 

Thirteen CytoCell® FISH probes that are important for the patient management of haematological cancers and pre-natal conditions have been IVDR-certified and are available to order. OGT will continue to pursue additional certifications for our CytoCell® FISH probe portfolio.

Haematology probes Product code
AML1 (RUNX1) Breakapart Probe CE-LPH027
AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion Probe CE-LPH026
BCR/ABL (ABL1) Translocation, Dual Fusion Probe CE-LPH007
BCR/ABL (ABL1) Plus Translocation, Dual Fusion Probe CE-LPH038
CBFB Breakapart Probe CE-LPH 089
CKS1B/CDKN2C (P18) Amplification/Deletion Probe CE-LPH039
Del(5q) Deletion Probe CE-LPH024
Del(7q) Deletion Probe CE-LPH025
Del(20q) Deletion Probe CE-LPH020
FAST PML/RARα (RARA) Translocation, Dual Fusion Probe CE-LPH064
IGH/MAF Plus v2 Translocation, Dual Fusion Probe CE-LPH108
MLL (KMT2A) Breakapart Probe CE-LPH013
Prenatal probes   
Prenatal 13 and 21 Enumeration Probe Kit CE-LPA003

Switch to a CytoCell® IVDR-certified FISH probe now and be assured that you won’t need to consider it again. Should you need any support, our expert team is always on hand to guide you through the transition.

Start the process early – contact your local Sysmex representative and request an evaluation kit today!

More details

View all CytoCell FISH probes

View all CytoCell ancillary products

CytoCell Tissue Pretreatment Kit

CytoCell Porcelain Wash Jars

OGT’s CytoCell® IVDR-certified range of fluorescence in situ hybridisation (FISH) probe kits are in vitro diagnostic (IVD) medical devices for the detection of prenatal trisomy 13 & 21 and acquired cancer-related chromosome alterations.  

They have been CE-marked under Regulation (EU) 2017/746 (IVDR) as Class C IVD medical devices for laboratory professional use only and are not intended for use as a standalone diagnostic or companion diagnostic.  

Refer to each individual FISH probe kit’s Instructions for use for their specific Intended purpose, indications, and limitations.”

Technical specifications
Probe

50µl per vial (5 tests) or 100µl per vial (10 tests), provided in hybridisation solution and are ready to use.

Counterstain

150µl per vial (15 tests), DAPI antifade

Storage temperature

-25°C to -15°C, in the dark

 

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You have a question and would like to get in touch with our experts? We look forward to receiving your enquiry.

Sysmex Europe SE

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22848 Norderstedt

Germany

+49 (40) 527 26 0

+49 (40) 527 26 100

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