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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
AML1/ETO Gene Fusion Probe Detection Kit (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Xl ETV6 Ba
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
EasyPGX ready NPM1 Screening
Diatech Pharmacogenetics SRL
·
,
Italy
Class C
CE/IVDR
SensiQuant PML/RARa Standard
Bioclarma S.R.L.
·
,
Italy
IVD General
CE/IVDD
Oncobit PM BRAF V600E2 PPM 40rxn
Oncobit AG
·
,
Switzerland
Class C
CE/IVDR
XCE 12 orange
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
XL t(10 +1 more model
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
FGFR3 Dual Color Break Apart Probe (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
EVI1 (MECOM) Breakapart Probe
Cytocell, Ltd.
·
,
United Kingdom
Class C
CE/IVDR
SensiScreen
PentaBase A/S
·
,
Denmark
IVD General
CE/IVDD
Xl TET2
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
EGR1 Gene Probe Detection Kit (fluorescence in situ hybridization)
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
TRUPCR® AML Panel Kit
3B BlackBio Dx Limited
·
,
India
Class C
CE/IVDR
p53/[CCND1/IGH]/ATM/CSP12/D13S25 gene Probe Detection Kit (fluorescence in situ…
Wuhan YZY Medical Science and Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
BCL6 (3q27) Proximal - XL
Leica Biosystems Newcastle, Limited
·
,
United Kingdom
IVD General
CE/IVDD
Oncomine™ Dx Target RNA Control Kit
Life Technologies Limited
·
,
United States
Class C
CE/IVDR
KIT D816V mutation digital PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
TruSight™ Oncology Comprehensive (EU) kit
Illumina, Inc.
·
,
United States
IVD General
CE/IVDD
IUterusure
Wuhan Ammunition Life-tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Xl MDM2
Metasystems Probes GmbH
·
,
Germany
Class C
CE/IVDR
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