Tests for acquired genetic or chromosomal alterations - other

W01060299 579 devices

PIK3CA-Q Real-Time PCR Kit

Genes 2Me Private Limited,India IVD General
Bladder Cancer Cell Chromosomal & Genetic Abnormalities Testing Kit (fluorescen…

Wuhan YZY Medical Science and Technology Co., Ltd,China IVD General
DDIT3 (12q13 Break

Leica Biosystems Newcastle, Limited,United Kingdom IVD General
Xl Dleu/Lamp

Metasystems Probes GmbH,Germany Class C
XL t(11 +1 more model

Metasystems Probes GmbH,Germany Class C
IDH1/IDH2 Gene Mutation Detection Kit

Gold Probe Diagnostic Biotechnology Inc. MF,China IVD General
UDI Primers Set C

4bases SA,Switzerland Class A
IGH/MAF Gene Fusion Probe Detection Kit (fluorescence in situ hybridization)

Wuhan YZY Medical Science and Technology Co., Ltd,China IVD General
Sentosa SA KRAS PCR Test (4x8)

Vela Operations Singapore Pte. Ltd.,Singapore IVD General
SensiQuant AML1-ETO Positive Control

Bioclarma S.R.L.,Italy IVD General
PDGFRB Dual Color Break Apart Probe (fluorescence in situ hybridization)

Wuhan YZY Medical Science and Technology Co., Ltd,China IVD General
TRUPCR® AML Panel Kit

3B BlackBio Dx Limited,India Class C
Oncobit PM NRASQ61R Control 10rxn

Oncobit AG,Switzerland Class C
SensiQuant PML/RARa Standard BCR2

Bioclarma S.R.L.,Italy IVD General
IGH (14q32) Break (tissue)

Leica Biosystems Newcastle, Limited,United Kingdom IVD General
Onco Check Panel

Genes 2Me Private Limited,India IVD General
TP63(3q28) Dual Color Break Apart Probe (fluorescence in situ hybridization)

Wuhan YZY Medical Science and Technology Co., Ltd,China IVD General
Human BCR-ABL(P210) Fusion Gene Detection Kit (Digital PCR Method)

Shenzhen Biorain biotechnology Co., Ltd.,China IVD General
XL del(5)(q31)

Metasystems Probes GmbH,Germany Class C
XL P2RY8 del

Metasystems Probes GmbH,Germany Class C