TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

EMDN W01060299

Parent W010602 ACQUIRED GENE OR CHROMOSOME ALTERATIONS

Registry term list. Not a clinical opinion. 745 devices carry this code.

Devices

Name	UDI-DI	Manufacturer	Class	Badge
ATM Deletion Probe	05055844906204	Cytocell Limited	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
ATM Deletion Probe	05055844906211	Cytocell Limited	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
ATM Deletion Probe	05055844923539	Cytocell Limited	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
ATM Deletion Probe	05055844923546	Cytocell Limited	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
ATM Gene Probe Detection Kit (fluorescence in situ hybridization)	06974604726151	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Barcode Set 1-16	76404133800590	4bases SA	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
B cell Receptor (BCR) Sequencing Panel	06975296640459	MEDx (Suzhou) Translational Medicine Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
BCL2 (18q21) Break (tissue)	08717973348184	Leica Biosystems Newcastle Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
BCL2 (18q21) Distal - XL	08717973349082	Leica Biosystems Newcastle Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
BCL2 Dual Color Break Apart Probe (fluorescence in situ hybridization)	06974604726373	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
BCL2/IGH Dual Color Dual Fusion Probe (fluorescence in situ hybridization)	06974604726106	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
BCL6 (3q27) Break (tissue)	08717973342854	Leica Biosystems Newcastle Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
BCL6 (3q27) Proximal - XL	08717973349099	Leica Biosystems Newcastle Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
BCL6 Dual Color Break Apart Probe (fluorescence in situ hybridization)	06974604726380	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
BCL6/IGH Gene Fusion Probe Detection Kit (fluorescence in situ hybridization)	06974604726625	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
BCR-ABL1 Genotyping Kit	06956299703068	Xiamen Zeesan Biotech Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
BCR-ABL1 p190 Kit	06956299703204	Xiamen Zeesan Biotech Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
BCR-ABL1 p210 Kit	06956299703211	Xiamen Zeesan Biotech Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
BCR/ABL Gene Fusion Probe Detection Kit(fluorescence in situ hybridization)	06974604723044	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
BCR-ABL Universal Real Time PCR Kit	08906178201664	Genes 2Me Private Limited	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Bladder Cancer Cell Chromosomal & Genetic Abnormalities Testing Kit (fluorescence in situ hybridization)	06974604723037	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
BRAF Codon 600 Mutation Analysis Kit II	05060536830101	EntroGen, Inc.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
BRAF V600E/D/R/K Mutations Detection Kit （Multiplex Real-time PCR）	06975977070605	Gold Probe Diagnostic Biotechnology Inc. MF	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Breast cancer–associated gene mutation digital PCR detection kit	06974689626575	TargetingOne Technology (Beijing) Corporation	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Breast cancer–associated gene mutation digital PCR detection kit	06974689627305	TargetingOne Technology (Beijing) Corporation	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Breast-Ovarian Cancer Combined Gene Detection Kit	06972665700004	XIAMEN SPACEGEN CO.,LTD.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Breast-Ovarian Cancer Combined Gene Detection Kit	06972665700219	XIAMEN SPACEGEN CO.,LTD.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
CBFB Breakapart Probe	05055844906761	Cytocell Limited	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
CBFB Breakapart Probe	05055844906778	Cytocell Limited	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
CBFB Dual Color Break Apart Probe (fluorescence in situ hybridization)	06974604726243	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
CBFB/MYH11 Gene Fusion Probe (fluorescence in situ hybridization)	06974604726236	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
CBFβ-MYH11 Detection Kit	06956299703235	Xiamen Zeesan Biotech Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
CCND1 (11q13) Proximal - XL	08717973349198	Leica Biosystems Newcastle Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
CCND1 Dual Color Break Apart Probe (fluorescence in situ hybridization)	06974604726458	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
CCND1/IGH Gene Fusion Probe Detection Kit (fluorescence in situ hybridization)	06974604726700	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
CCND3/IGH Gene Fusion Probe (fluorescence in situ hybridization)	06974604726168	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
CDKN2A Gene Deletion Probe Detection Kit (fluorescence in situ hybridization)	06974604726311	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Cervical cancer-associated gene methylation digital PCR detection kit	06974689626698	TargetingOne Technology (Beijing) Corporation	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Cervical cancer-associated gene methylation digital PCR detection kit	06974689627398	TargetingOne Technology (Beijing) Corporation	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
CHIC2 Gene Deletion Probe Detection Kit (fluorescence in situ hybridization)	06974604726045	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Chr7/Chr17/Chr3/P16 gene Probe Detection Kit (fluorescence in situ hybridization)	06974604723020	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Chromosome 12 Centromere Probe (CEP12) Kit (fluorescence in situ hybridization)	06974604726144	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
chromosome8 20q Probe Detection Kit (fluorescence in situ hybridization)	06974604726793	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Chromosome 8 Centromere Probe (CEP8) Kit(fluorescence in situ hybridization)	06974604723013	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
CKS1B/CDKN2C (P18) Amplification/Deletion Probe	05055844906525	Cytocell Limited	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
CKS1B/CDKN2C (P18) Amplification/Deletion Probe	05055844906532	Cytocell Limited	Class C	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
c-MET Exon 14 Skipping RT-qPCR Test	06975296640497	MEDx (Suzhou) Translational Medicine Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Coffalyser.Net	08720211482816	MRC Holland B.V.	Class A	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
ColoClear	06971980730161	Hangzhou New Horizon Health Technology Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED
Colorectal cancer methylation digital PCR panel	06974689626025	TargetingOne Technology (Beijing) Corporation	Unknown class	No Certificate Found Snapshot 2026-10-13 · Link to EUDAMED