Tests for acquired genetic or chromosomal alterations - other

W01060299 579 devices

Pan Cancer Panel

Genes 2Me Private Limited,India IVD General
TRUPCR® KRAS Kit

3B BlackBio Dx Limited,India Class C
Del(5q) Deletion Probe

Cytocell, Ltd.,United Kingdom Class C
Haematology OncoKitDx

Health in Code, S.L.,Spain IVD General
TarCET Kit - Carrier Screening Core Panel

Medicover Genetics Limited,Cyprus Class A
EGFR/KRAS/ALK Gene Mutation Detection Kit (Combinatorial Probe-Anchor Synthesis…

Bgi Europe A/S,Denmark IVD General
Lung cancer digital PCR panel

TargetingOne Technology (Beijing) Corporation,China IVD General
D7S522 Gene Probe Detection Kit (fluorescence in situ hybridization)

Wuhan YZY Medical Science and Technology Co., Ltd,China IVD General
AmoyDx® Multi-Gene Mutations Detection Kit

Amoy Diagnostics Co., LTD.,China IVD General
XL MECOM 3q26

Metasystems Probes GmbH,Germany Class C
Lung cancer-associated gene mutation digital PCR detection kit

TargetingOne Technology (Beijing) Corporation,China IVD General
IGH (14q32) Distal - XL

Leica Biosystems Newcastle, Limited,United Kingdom IVD General
Oncobit PM NRASQ61K PPM 40rxn

Oncobit AG,Switzerland Class C
TRUPCR® BCR-ABL Kit – Qualitative Major, Minor & Micro

3B BlackBio Dx Limited,India Class C
FOXO1 (13q14) Break

Leica Biosystems Newcastle, Limited,United Kingdom IVD General
Common Hereditary Cancer NGS Panel

Genes 2Me Private Limited,India IVD General
XL 4q12 DC

Metasystems Probes GmbH,Germany Class C
BCL6 (3q27) Break (tissue)

Leica Biosystems Newcastle, Limited,United Kingdom IVD General
Oncomine™ Dx Express Test FFPE DNA Control

Life Technologies Limited,United States IVD General
OncoMate® 5C Matrix Standard

Promega Corporation,United States IVD General