538 results · 19ms · Sources: EU EUDAMED, US FDA

Human Papillomavirus (HPV) Nucleic Acid Detection Kit (Hybrid Capture-CLIA)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Hangzhou Dalton BioSciences, Ltd.·4 devices

U/CSF Protein

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Thermo Fisher Scientific Oy·1 device

Glucose (HK)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Thermo Fisher Scientific Oy·2 devices

Glucose (GOD-POD)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Thermo Fisher Scientific Oy·2 devices

Amylase (IFCC)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Thermo Fisher Scientific Oy·1 device

CK-MB

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Thermo Fisher Scientific Oy·2 devices

Serum Amyloid A Calibrator、Serum Amyloid A Control

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices

C-Reactive Protein (CRP) Kit (Latex Immunoturbidimetric Method)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·1 device

Evidence MultiSTAT Drugs of Abuse (DOA) ToxPlex Urine Array

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Randox Laboratories Limited·1 device

Dengue NS1 Rapid Test

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Hangzhou Alltest Biotech.Co.,Ltd.·2 devices

PIVKA-II (CLIA),PIVKA-II Calibrators,PIVKA-II Control

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·11 devices

NanoTYPE

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Omixon Biocomputing Ltd.·3 devices

One Lambda Devyser Chimerism

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Devyser AB·2 devices

LYNOAMP CK19 E

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·SYSMEX CORPORATION·1 device

RTPCR026

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Vircell, S.L·1 device

IGE

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Medicon Hellas SA·6 devices

CREATININE ENZ

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Medicon Hellas SA·4 devices

CK

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Medicon Hellas SA·4 devices

CK-MB

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Medicon Hellas SA·8 devices

DNA Methylation Detection Kit for Human SDC2, ADHFE1 and PPP2R5C Genes (Real-Time PCR)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·ENVELOPE HEALTH BIOTECHNOLOGY CO., LTD.·2 devices