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In vitro diagnostic medical devices
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Genetic testing
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Acquired gene or chromosome alterations
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Tests for acquired genetic or chromosomal alterations - other
Tests for acquired genetic or chromosomal alterations - other
W01060299
579 devices
Devices
Xl KMT2A Ba
Metasystems Probes GmbH
·
,
DE
Class C
CE/IVDR
PAX5/IGH Gene Fusion Probe Detection Kit (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
CN
IVD General
CE/IVDD
EVI1 (MECOM) Breakapart Probe
Cytocell Limited
·
,
GB
Class C
CE/IVDR
XCE 12 blue
Metasystems Probes GmbH
·
,
DE
Class C
CE/IVDR
CSF1R(5q32) Dual Color Break Apart Probe (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
CN
IVD General
CE/IVDD
Human EGFR Gene Mutation Detection Kit (PCR-Fluorescence Method)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
CN
IVD General
CE/IVDD
TRUPCR® MPN Panel Kit
3B BlackBio Dx Limited
·
,
IN
Class C
CE/IVDR
MYD88 L265P mutation digital PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
CN
IVD General
CE/IVDD
11q23.3/11q24.3 Gene Deletion Probe (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
CN
IVD General
CE/IVDD
TRUPCR® HPV High Risk Genotyping Kit
3B BlackBio Dx Limited
·
,
IN
Class C
CE/IVDR
SS18 (18q11) Distal - XL
Leica Biosystems Newcastle, Limited
·
,
GB
IVD General
CE/IVDD
TRUPCR® PML-RARA Kit - Quantitative
3B BlackBio Dx Limited
·
,
IN
Class C
CE/IVDR
ZNF154 gene methylation digital PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
CN
IVD General
CE/IVDD
XL del(7)(q22q31)
Metasystems Probes GmbH
·
,
DE
Class C
CE/IVDR
PML-RARA digital PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
CN
IVD General
CE/IVDD
Human HLA-B*1502 Gene Nucleic Acid Detection Kit (Fluorescence PCR Method)
Suzhou TianLong Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
IHepcomf
Wuhan Ammunition Life-tech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Lung cancer-associated gene methylation digital PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
CN
IVD General
CE/IVDD
Diagnostic Kit for Methylated Genes of Lung Cancer(Real Time PCR)
Excellen Medical Technology Co., Ltd.
·
,
CN
Class C
CE/IVDR
XL t(14 +1 more model
Metasystems Probes GmbH
·
,
DE
Class C
CE/IVDR
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