1,072 results
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8ms
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Sources: EU EUDAMED, US FDA
Hair Ketamine (KET) Test Kit (Fluorescence Immunochromatographic Assay)
Device
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·On the market
Hair Morphine (MOP)/ Methamphetamine (MET)/ Ketamine (KET) Multi Drug Test Kit
Device
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·On the market
Hair Ketamine (KET) Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
Hair Morphine (MOP)/ Methamphetamine (MET)/ Ketamine (KET) Multi Drug Test Kit (Fluorescence Immunochromatographic Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen Superbio Technology Co.,Ltd.·1 device
ORAgene (Swab-based DNA & Dx Collection Device)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·DNA Genotek Inc.·4 devices
AAV5 NAb Test Specimen Collection Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Precision for Medicine, Inc.·1 device
AutoLumo analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Autobio Diagnostics Co., Ltd.·2 devices
ProGRP Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
D-Dimer Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
CA 125 Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
TG Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
Ferritin Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
NSE Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
CA 15-3 Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
CA 72-4 Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
CA 19-9 Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
CEA Assay (CLIA)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Zybio Inc.·1 device
INSTI HIV-1/HIV-2 ANTIBODY TEST KIT
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·bioLytical Laboratories Inc.·1 device
iSTATIS COVID-19 Ag HOME TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·1 device
iSTATIS COVID-19 Ag HOME TEST
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·bioLytical Laboratories Inc.·1 device