Tests for acquired genetic or chromosomal alterations - other

W01060299 579 devices

UDI Primers Set D

4bases SA,Switzerland Class A
IDH1 mutation digital PCR detection kit

TargetingOne Technology (Beijing) Corporation,China IVD General
TRUPCR® DPYD Mutations Detection Kit

3B BlackBio Dx Limited,India Class C
ATM Gene Probe Detection Kit (fluorescence in situ hybridization)

Wuhan YZY Medical Science and Technology Co., Ltd,China IVD General
PlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay

PentaBase A/S,Denmark Class C
TRUPCR® KRAS Kit

3B BlackBio Dx Limited,India Class C
XL CBFB/MYH11 plus

Metasystems Probes GmbH,Germany Class C
XL 20q12/20qter/8cen plus

Metasystems Probes GmbH,Germany Class C
Human 10-Gene Mutation Detection Kit

iCarbonX IntelliCore (Guangdong) Co., Ltd.,China IVD General
SensiScreen

PentaBase A/S,Denmark IVD General
Del(7q) Deletion Probe

Cytocell, Ltd.,United Kingdom Class C
Xl SPI1 Ba

Metasystems Probes GmbH,Germany IVD General
Multi-Gene Methylation Detection Kit for Human Liver Cancer (PCR-Fluorescence P…

Singlera Genomics (Jiangsu) Ltd.,China IVD General
NTRK1 Dual Color Break Apart Probe (fluorescence in situ hybridization)

Wuhan YZY Medical Science and Technology Co., Ltd,China IVD General
Ion Torrent™ Oncomine™ Dx Express Test Panel

Life Technologies Limited,United States IVD General
SensiQuant Direct AML1-ETO MasterMix

Bioclarma S.R.L.,Italy IVD General
Oncobit PM BRAF V600E Control 50rxn

Oncobit AG,Switzerland Class C
11q23DLEU1 Gene Deletion Probe Detection Kit (fluorescence in situ hybridizatio…

Wuhan YZY Medical Science and Technology Co., Ltd,China IVD General
EGFR-Q Real-Time PCR Kit

Genes 2Me Private Limited,India IVD General
c-MET Exon 14 Skipping RT-qPCR Test

MEDx (Suzhou) Translational Medicine Co., Ltd.,China IVD General