36 results · 9ms · Sources: EU EUDAMED, US FDA

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EarlyCDT Lung Test Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Freenome Ltd·1 device

Syphilis Rapid Test

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Hangzhou Alltest Biotech.Co.,Ltd.·9 devices

HPV Genotyping Kit (18 Types)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Guangzhou KingCreate Biotechnology Co., Ltd.·1 device

iFlash-Total β HCG

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·SHENZHEN YHLO BIOTECH CO., LTD.·3 devices

iFlash-Calcitonin

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

iFlash-CRP

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·SHENZHEN YHLO BIOTECH CO., LTD.·3 devices

iFlash-hs-cTnI

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

iFlash-PIVKA-Ⅱ

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

iFlash-NT-proBNP

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

D-dimer Assay Kits (Lateral Flow Immunoassay)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Lifotronic Technology Co., Ltd.·4 devices

Chlamydia and Gonorrhea Antigen Rapid Test Kit

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

SARS-CoV-2 & Influenza A+B & RSV & ADV Antigen Combo Test Kit (Colloidal Gold)

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EU IVDR · Eu Ivd Class C ·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·1 device

Procalcitonin(CLIA)、PCT Calibrators、PCT Control

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EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·7 devices

Insulin(CLIA)、Insulin Calibrators

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

Carbohydrate Antigen 242(CLIA)、CA 242 Calibrators

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

Immunoassay Multi Control

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

Herpes Simplex Virus 1+2 IgM(CLIA)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices

Herpes Simplex Virus 1+2 IgG(CLIA)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices

Herpes Simplex Virus-2 IgG(CLIA)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·4 devices

Tumor Marker Control II

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·7 devices