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In vitro diagnostic medical devices
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Genetic testing
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Inborn gene or chromosome alterations
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Monogenetic disorders
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Monogenetic disorders tests - other
Monogenetic disorders tests - other
W0106010199
125 devices
LAMP Human MTHFR mutation KIT (rs1801133)
Lacar MDX Technologies
·
,
Belgium
IVD General
CE/IVDD
SPOT-it TREC, KREC & SMN1 Screening Kit
ImmunoIVD AB
·
,
Sweden
IVD General
CE/IVDD
PCR-CE SMN1/2 Kit
Xiamen Biofast Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
ZENA MAX MTHFR (A1298C) Real Time PCR Detection Kit
Advanced Molecular Diagnostics Ltd
·
,
United Kingdom
IVD General
CE/IVDD
Methylene tetrahydrofolate reductase (MTHFR) Diagnostic Kit (PCR-Fluorescence P…
Shenzhen Zijian Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
Blueprint Genetics WES Platform – Proband Seq
Blueprint Genetics Oy
·
,
Finland
IVD General
CE/IVDD
ZENA MAX Janus Kinase 2 (JAK2) V617F Real Time PCR Detection Kit
Advanced Molecular Diagnostics Ltd
·
,
United Kingdom
IVD General
CE/IVDD
PCR-CE NOTCH2NLC Kit
Xiamen Biofast Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
PCR-CE SMN1/2 Kit
Xiamen Biofast Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
TGS Human MTHFR (C677T) Gene Polymorphism Detection Kit
Wuxi Ruiqi Gene Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
SPOT-it TREC Screening Kit
ImmunoIVD AB
·
,
Sweden
Class C
CE/IVDR
AmplideX SMA Plus Kit (100 rxn)
Asuragen, Inc.
·
,
United States
IVD General
CE/IVDD
SALSA MLPA Probemix P226 SDH
MRC Holland B.V.
·
,
Netherlands
Class C
CE/IVDR
Inherited CardioKitDx
Health in Code, S.L.
·
,
Spain
IVD General
CE/IVDD
A1AT Genotyping Test Reagents
Progenika Biopharma, S.A.
·
,
Spain
Class C
CE/IVDR
GUDID
on market
SALSA MLPA Probemix P008 PMS2
MRC Holland B.V.
·
,
Netherlands
Class C
CE/IVDR
LAMP Human Lactose Intolerance KIT
Lacar MDX Technologies
·
,
Belgium
IVD General
CE/IVDD
Blueprint Genetics WES Platform – Variant Seq
Blueprint Genetics Oy
·
,
Finland
IVD General
CE/IVDD
Blueprint Genetics Sanger Platform
Blueprint Genetics Oy
·
,
Finland
IVD General
CE/IVDD
Spinal Muscular Atrophy Genetic Testing Kit (PCR-Fluorescence Probing)
Yaneng BIOscience (Shenzhen) Co., Ltd.
·
,
China
IVD General
CE/IVDD
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