60 results
·
8ms
·
Sources: EU EUDAMED, US FDA
Colloidal Gold Reader
Device
EU IVDR
·
Eu Ivd Class A
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·Not intended for eu market
Colloidal Gold Reader
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Shenzhen Kang Sheng Bao Bio-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
Wash Buffer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Zybio Inc.·6 devices
Sample Diluent
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Zybio Inc.·2 devices
Substrate
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Zybio Inc.·2 devices
AutoLumo analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Autobio Diagnostics Co., Ltd.·1 device
AAV5 DetectCDx™ Specimen Shipping Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·ARUP Laboratories Inc·1 device
Procise Stool Collection Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·ProciseDx Inc.·2 devices
Oncotype Sample Prep Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Genomic Health Inc.·2 devices
48 rxn;96 rxn
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Xukang Medical Technology (Suzhou) Co., Ltd.·2 devices
24 tubes;12 tubes
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Xukang Medical Technology (Suzhou) Co., Ltd.·2 devices
-
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Xukang Medical Technology (Suzhou) Co., Ltd.·2 devices
-
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Xukang Medical Technology (Suzhou) Co., Ltd.·4 devices
Cell-free DNA Extraction Kit (Magnetic Bead Method)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Zybio Inc.·1 device
24 rxns
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Xukang Medical Technology (Suzhou) Co., Ltd.·1 device
Ab Matrix Solution
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Zybio Inc.·1 device
AutoLumo analyzer
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Autobio Diagnostics Co., Ltd.·1 device