Tests for acquired genetic or chromosomal alterations - other

W01060299 579 devices

FAST PML/RARα (RARA) Translocation, Dual Fusion Probe

Cytocell, Ltd.,United Kingdom Class C
XL 6q21/6q23

Metasystems Probes GmbH,Germany Class C
Xl CDKN2C/CKS1B

Metasystems Probes GmbH,Germany Class C
AmoyDx® PIK3CA Mutation Detection Kit

Amoy Diagnostics Co., LTD.,China IVD General
IEsohunter

Wuhan Ammunition Life-tech Co., Ltd.,China IVD General
XL 5q32 PDGFRB BA

Metasystems Probes GmbH,Germany Class C
CKS1B/CDKN2C (P18) Amplification/Deletion Probe

Cytocell, Ltd.,United Kingdom Class C
JAK2 Dual Color Break Apart Probe (fluorescence in situ hybridization)

Wuhan YZY Medical Science and Technology Co., Ltd,China IVD General
Human NRAS Gene Mutations Detection Kit (PCR-Fluorescence Method)

Wuhan YZY Medical Science and Technology Co., Ltd,China IVD General
D20S108/20q11 Gene Probe Detection Kit (fluorescence in situ hybridization)

Wuhan YZY Medical Science and Technology Co., Ltd,China IVD General
Oncomine™ Dx Target RNA Control Diluent

Life Technologies Limited,United States Class C
Genexpath

Genexpath,France IVD General
SensiQuant Direct PML/RARa MasterMix

Bioclarma S.R.L.,Italy IVD General
ESWR1 (22q12) Proximal - XL

Leica Biosystems Newcastle, Limited,United Kingdom IVD General
AML1-ETO digital PCR detection kit

TargetingOne Technology (Beijing) Corporation,China IVD General
XL 20q12/20qter plus

Metasystems Probes GmbH,Germany Class C
TRUPCR® JAK 2 QT Kit (Allele Burden)

3B BlackBio Dx Limited,India Class C
CancerCheck Core Panel

Genes 2Me Private Limited,India IVD General
Oncobit PM BRAF V600E PPM 200rxn

Oncobit AG,Switzerland Class C
Genexpath

Genexpath,France IVD General