538 results · 17ms · Sources: EU EUDAMED, US FDA

Cancer Antigen 19-9 test (Chemiluminescence Immunoassay)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·1 device

Human Epididymis Protein 4 test (Chemiluminescence Immunoassay)

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EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·1 device

Procalcitonin test (chemiluminescence immunoassay)

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EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·1 device

High sensitive Cardiac Troponin-I test (Chemiluminescence Immunoassay)

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EU IVDR · Eu Ivd Class C ·Beijing Hotgen Biotech Co., Ltd.·1 device

EpiDirect® MLH1 Methylation qPCR Assay

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EU IVDR · Eu Ivd Class C ·PentaBase A/S·1 device

AutoLumo analyzer

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EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·2 devices

iFlash-IL-6

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EU IVDR · Eu Ivd Class C ·SHENZHEN YHLO BIOTECH CO., LTD.·2 devices

AutoLumo analyzer

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·3 devices

AutoLumo analyzer

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EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·2 devices

sthemO Anti-Xa

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EU IVDR · Eu Ivd Class C ·Diagnostica Stago·1 device

sthemO DDi

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EU IVDR · Eu Ivd Class C ·Diagnostica Stago·1 device

D-DIMER

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EU IVDR · Eu Ivd Class C ·Medicon Hellas SA·6 devices

STFR

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EU IVDR · Eu Ivd Class C ·Medicon Hellas SA·6 devices

STA® - Dabigatran Control

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EU IVDR · Eu Ivd Class C ·Diagnostica Stago·1 device

RTPCR007

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EU IVDR · Eu Ivd Class C ·Vircell, S.L·1 device

Immunoassay Multi Control

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EU IVDR · Eu Ivd Class C ·SHENZHEN EVER-BLUE BIOTECH CO., LTD.·1 device

Tumor Marker Multi Control

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EU IVDR · Eu Ivd Class C ·SHENZHEN EVER-BLUE BIOTECH CO., LTD.·1 device

FIT Hemoglobin NS-Prime

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EU IVDR · Eu Ivd Class C ·Alfresa Pharma Corporation·1 device

FIT Hemoglobin AA01

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Alfresa Pharma Corporation·1 device

iFlash-ProGRP

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·SHENZHEN YHLO BIOTECH CO., LTD.·2 devices