10,000 results
·
42ms
·
Sources: EU EUDAMED, US FDA
ORAgene
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·9 devices
ORAgene (Swab-based DNA & Dx Collection Device)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·4 devices
OMNIgene GUT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·1 device
OMNIgene ORAL
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·2 devices
OG-AC1
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·DNA Genotek Inc.·1 device
ORAcollect (Swab based RNA Collection Device)
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·DNA Genotek Inc.·1 device
ORAcollect (Swab based DNA & Dx Collection Device)
Basic UDI-DI
EU MDR
·
Eu Md Class 1
·DNA Genotek Inc.·3 devices
1434-IVDD-254/2022
Certificate
IVDD Annex III Section 6·Shenzhen Superbio Technology Co.,Ltd.·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·3 Basic UDI-DIs
Immunofluorescence Analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Guangzhou Decheng Biotechnology Co., Ltd.·1 device
β-HCG Assay kit CLIA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
β-HCG Assay kit CLIA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
TT4 Assay kit CLIA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
TT4 Assay kit CLIA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
TT3 Assay kit CLIA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
TT3 Assay kit CLIA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
TSH Assay kit CLIA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
TSH Assay kit CLIA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
tPAIC Assay kit CLIA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
tPAIC Assay kit CLIA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
TM Assay kit CLIA
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device