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In vitro diagnostic medical devices
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Genetic testing
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Genetic tests - other
Genetic tests - other
W010699
865 devices
Comprehensive Multi-Gene Variant Assay
Suzhou GenePlus Biomedical Engineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
ALK/ROS1/MET gene fusions and mutations real-time PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
Universal Sequencing Reaction Kit T7 FCL PE100
Wuhan MGI Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
Laborant Total Nucleic Acid Extraction Kit (96)
Ant Medi̇kal İthalat İhracat Pazarlama Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
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,
Türkiye
Class A
CE/IVDR
Devyser RHD
Devyser AB
·
,
Sweden
IVD General
CE/IVDD
Universal Sequencing Reaction Kit T1+ FCL PE150
Shenzhen MGI Biological Electronic Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Human Papillomavirus Gene Test Kit (PCR-Fluorescence)
Guangzhou LBP Medicine Science & Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
APOL1 Genotyping Test
Laboratory Corporation of America Holdings
·
,
United States
IVD General
CE/IVDD
SureID®23comp Human DNA Identification Kit
Ningbo HEALTH Gene Technologies Co., LTD.
·
,
China
IVD General
CE/IVDD
VAHTS DNA Library Prep Kit for Illumina
Nanjing Vazyme Medical Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Prosigna Breast Cancer Prognostic Gene Signature Assay
Veracyte, Inc
·
,
United States
IVD General
CE/IVDD
Twist Precision Prep and Enrichment Dx Kit, 96 samples (A) - Box 1
Twist Bioscience Corporation
·
,
United States
Class A
CE/IVDR
Onco-GeneSGKit X 12 reacciones
Sistemas Genomicos. S.L.
·
,
Spain
IVD General
CE/IVDD
Universal Sequencing Reaction Kit G50 SM FCS SE100
Wuhan MGI Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
KMRtrack® KMR019
Genome Diagnostics B.V.
·
,
Netherlands
IVD General
CE/IVDD
Almac TP53 Clinical Trial Assay (CTA) v3
Almac Diagnostic Services Limited
·
,
Northern Ireland
IVD General
CE/IVDD
K-ras Gene Mutations Detection Kit (Multiplex Fluorescence Polymerase Chain Rea…
Xiamen Spacegen Co., Ltd.
·
,
China
IVD General
CE/IVDD
SIRPA qPCR Clinical Trial Assay (CTA)
Almac Diagnostic Services Limited
·
,
Northern Ireland
IVD General
CE/IVDD
KMRtrack® KMR004
Genome Diagnostics B.V.
·
,
Netherlands
IVD General
CE/IVDD
BRCA1/2 Gene Mutations Detection Kit (High Throughput Sequencing)
Xiamen Spacegen Co., Ltd.
·
,
China
IVD General
CE/IVDD
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