Tests for acquired genetic or chromosomal alterations - other

W01060299 579 devices

GynTect

Epitype GmbH,Germany Class C
Genexpath

Genexpath,France IVD General
Colosafe

Creative Biosciences (Guangzhou) Co., Ltd.,China IVD General
Oncobit PM GNAQ209L Control 10rxn

Oncobit AG,Switzerland Class C
AML1-ETO Detection Kit

Xiamen Zeesan Biotech Co., Ltd.,China IVD General
Sentosa SQ Thyroid Cancer Panel (4x8)

Vela Operations Singapore Pte. Ltd.,Singapore IVD General
Human B Lymphocyte Minimal Residual Disease Detection Kit

Genetron Health (Beijing) Co., Ltd.,China IVD General
Xl NUP98

Metasystems Probes GmbH,Germany Class C
RARA Dual Color Break Apart Probe (fluorescence in situ hybridization)

Wuhan YZY Medical Science and Technology Co., Ltd,China IVD General
Del(7q) Deletion Probe

Cytocell, Ltd.,United Kingdom Class C
TP53 Gene Deletion Probe Detection Kit (fluorescence in situ hybridization)

Wuhan YZY Medical Science and Technology Co., Ltd,China IVD General
geneMAP

Genmark Sağlik Ürünleri̇ İthalat İhracat Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇,Türkiye IVD General
EGFR Ex19Del/L858R/T790M mutations digital PCR detection kit

TargetingOne Technology (Beijing) Corporation,China IVD General
Breast cancer–associated gene mutation digital PCR detection kit

TargetingOne Technology (Beijing) Corporation,China IVD General
Diagnostic Kit for Methylated Genes of Breast Cancer（Real Time PCR）

Excellen Medical Technology Co., Ltd.,China Class C
XL t(11 +1 more model

Metasystems Probes GmbH,Germany Class C
IDH1 mutation digital PCR detection kit

TargetingOne Technology (Beijing) Corporation,China IVD General
CCND1 (11q13) Proximal - XL

Leica Biosystems Newcastle, Limited,United Kingdom IVD General
TRUPCR® CALR Kit

3B BlackBio Dx Limited,India Class C
TarCET Kit - Arrhythmia Panel

Medicover Genetics Limited,Cyprus Class A