TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

EMDN W01060299

Parent W010602 ACQUIRED GENE OR CHROMOSOME ALTERATIONS

Registry term list. Not a clinical opinion. 728 devices carry this code.

Devices

Name	UDI-DI	Manufacturer	Class	Badge
11q23.3/11q24.3 Gene Deletion Probe (fluorescence in situ hybridization)	06974604726687	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
11q23DLEU1 Gene Deletion Probe Detection Kit (fluorescence in situ hybridization)	06974604726083	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
12/D13S25 Gene Deletion Probe Detection Kit (fluorescence in situ hybridization)	06974604726113	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
1p/19q Deletion Probe Detection Kit (fluorescence in situ hybridization)	06974604726557	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
5q Probe Detection Kit (fluorescence in situ hybridization)	06974604726861	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
6q Probe Detection Kit (fluorescence in situ hybridization)	06974604726137	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
7q11.23 Deletion Probe Detection Kit (fluorescence in situ hybridization)	06974604726878	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
7q Probe Detection Kit (fluorescence in situ hybridization)	06974604726205	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ABL1/ABL2/PDGFRB/CRLF2/JAK2 Gene Break Apart Probe (fluorescence in situ hybridization)	06974604726366	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
Action OncoKitDx (Automatic)	08436589881303	Health in Code S.L.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ALK Dual Color Break Apart Probe (fluorescence in situ hybridization)	06974604723105	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ALK/ROS1/MET gene fusions and mutations digital PCR detection kit	06974689626131	TargetingOne Technology (Beijing) Corporation	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ALK/ROS1/MET gene fusions and mutations digital PCR detection kit	06974689627121	TargetingOne Technology (Beijing) Corporation	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AML1 Dual Color Break Apart Probe (fluorescence in situ hybridization)	06974604726274	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AML1-ETO Detection Kit	06956299703020	Xiamen Zeesan Biotech Co., Ltd.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AML1-ETO digital PCR detection kit	06974689626759	TargetingOne Technology (Beijing) Corporation	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AML1-ETO digital PCR detection kit	06974689627459	TargetingOne Technology (Beijing) Corporation	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AML1/ETO Gene Fusion Probe Detection Kit (fluorescence in situ hybridization)	06974604723068	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion Probe	05055844906402	Cytocell Limited	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion Probe	05055844906419	Cytocell Limited	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AML1 (RUNX1) Breakapart Probe	05055844906426	Cytocell Limited	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AML1 (RUNX1) Breakapart Probe	05055844906433	Cytocell Limited	Class C	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® BRAF V600 Mutations Detection Kit	06959094206062	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® EGFR 29 Mutations Detection Kit	06959094206024	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® EGFR 29 Mutations Detection Kit	06959094210595	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® Essential NGS Panel	06959094210588	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® HANDLE Classic NGS Panel	06959094210557	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® HANDLE HRR NGS Panel	06959094212384	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® HRD Complete Panel	06959094210274	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® HRD Complete Panel	06959094212070	Amoy Diagnostics Co., LTD.	Class C	Certificate valid Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® HRD Focus Panel	06959094210564	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit	06959094210649	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit	06959094210922	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® KRAS/NRAS/BRAF Mutations Detection Kit	06959094210939	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® KRAS/NRAS Mutations Detection Kit	06959094206192	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® KRAS/NRAS Mutations Detection Kit	06959094210885	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® Multi-Gene Mutations Detection Kit	06959094210991	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® Multi-Gene Mutations Detection Kit	06959094211004	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® NRAS Mutation Detection Kit	06959094206130	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® NRAS Mutation Detection Kit	06959094210762	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® NRAS Mutation Detection Kit	06959094210786	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® Pan Lung Cancer PCR Panel	06959094210809	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® Pan Lung Cancer PCR Panel	06959094210816	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® PIK3CA Mutation Detection Kit	06959094210953	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® ROS1 Gene Fusions Detection Kit	06959094210571	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® ROS1 Gene Fusions Detection Kit	06959094210830	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® ROS1 Gene Fusions Detection Kit	06959094210847	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
AmoyDx® ROS1 Gene Fusions Detection Kit	06959094212636	Amoy Diagnostics Co., LTD.	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
API2/MALT1 Gene Fusion Probe Detection Kit (fluorescence in situ hybridization)	06974604726441	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED
ASS gene Probe Detection Kit (fluorescence in situ hybridization)	06974604726038	Wuhan YZY Medical Science and Technology Co., Ltd	Unknown class	No Certificate Found Snapshot 2026-10-09 · Link to EUDAMED