Available now! The first IVDR-certified probes on the market
Safe, reliable and effective products for you and your patients
Haematological cancers and prenatal conditions
Commitment to transition the entire CytoCell^® IVDD portfolio to IVDR by the 31 December 2028 deadline.

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 were 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 testing 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.

The full CytoCell^® IVDD portfolio will be transitioned to IVDR, alongside a broad range of non-IVDD and existing custom myProbes^®, with a clear roadmap to full IVDR transition ahead of the 31 December 2028 deadline.

This ensures continuity of supply and regulatory confidence, enabling you to move seamlessly from IVDD to IVDR with a trusted partner.

Supported by a comprehensive portfolio and expert guidance throughout validation and implementation, you can switch with confidence.

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

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
CBFβ (CBFB)/MYH11 Translocation, Dual Fusion Probe	CE-LPH022
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
EVI1 (MECOM) Breakapart Probe	CE-LPH036
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
P53 (TP53)/ATM Combination Deletion Probe	CE-LPH052
Prenatal probes
Prenatal Enumeration Probe Kit	CE-LPA001
FAST FISH Prenatal Enumeration Probe Kit	CE-LPF001
Prenatal 13 and 21 Enumeration Probe Kit	CE-LPA003

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.

More details

View all CytoCell FISH probes

View all CytoCell ancillary products

EUDAMED

BSI

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