10,000 results
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44ms
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Sources: EU EUDAMED, US FDA
NextSeq 550Dx Sequencing System
FDA UDI
ILLUMINA, INC.·00816270020125·The Illumina NextSeq 550Dx instrument is intend...
MiSeq™ Dx (China)
FDA UDI
ILLUMINA, INC.·00816270020699·The Illumina MiSeqDx is intended for targeted s...
ePlex
FDA UDI
GENMARK DIAGNOSTICS, INC.·00857167005009·
MiSeqDx Instrument
FDA UDI
ILLUMINA, INC.·00816270020002·The Illumina MiSeqDx is a sequencing instrument...
NovaSeq™ 6000Dx
FDA UDI
ILLUMINA, INC.·00816270020637·The NovaSeq™ 6000Dx Instrument is intended for ...
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
FDA Pre-Market Approval
FDA Class 3
·T-SPOT. TB TEST
Sharay APS IgG (CLIA)
Device
EU IVDD
·
Eu Ivd General
·C-Luminary Biotechnology Co., Ltd.·No longer on the market
Reagena PUUMALA IgG EIA
Device
EU IVDD
·
Eu Ivd General
·Reagena Oy·On the market
ReaScan+ C6 LYME IgG
Device
EU IVDD
·
Eu Ivd General
·Reagena Oy·On the market
IgG / IgG4 Vorscreen OMNI
Device
EU IVDD
·
Eu Ivd General
·Gold Standard Diagnostics Kassel GmbH·On the market
CLIA Parvovirus B19 IgG
Device
EU IVDR
·
Eu Ivd Class C
·TestLine Clinical Diagnostics s.r.o.·On the market·32 countries
SpermMar Test IgG antiserum
Device
EU IVDR
·
Eu Ivd Class B
·FertiPro·On the market·32 countries
BlueWell Intrinsic Factor IgG
Device
EU IVDD
·
Eu Ivd General
·D-tek s.a.·On the market·18 countries
BlueWell ASCA IgG ELISA
Device
EU IVDD
·
Eu Ivd General
·D-tek s.a.·On the market·18 countries
Toxo IgG CLIA Microparticles
Device
EU IVDR
·
Eu Ivd Class C
·Autobio Diagnostics Co., Ltd.·On the market·3 countries
CMV IgG CLIA Microparticles
Device
EU IVDR
·
Eu Ivd Class C
·Autobio Diagnostics Co., Ltd.·On the market·3 countries
AutoLumo ANA IgG Calibrators
Device
EU IVDR
·
Eu Ivd Class B
·Autobio Diagnostics Co., Ltd.·On the market·1 country
ANA IgG CLIA Microparticles
Device
EU IVDR
·
Eu Ivd Class B
·Autobio Diagnostics Co., Ltd.·On the market·1 country
AutoLumo RF IgG Calibrators
Device
EU IVDR
·
Eu Ivd Class B
·Autobio Diagnostics Co., Ltd.·On the market·1 country
RF IgG CLIA Microparticles
Device
EU IVDR
·
Eu Ivd Class B
·Autobio Diagnostics Co., Ltd.·On the market·1 country