116 results · 7ms · 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

Glucose Kit (HK Method)

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

HPV Genotyping Kit (18 Types)

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

α-Amylase Kit (IFCC Method)

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

Glucose Kit (GOD-POD Method)

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

ZIKV/DENV/CHIKV REALTIME PCR KIT

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

Human Papillomavirus DNA Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Sansure Biotech Inc.·1 device

α-L-Fucosidase Kit (CNPF Method)、AFU Control

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

Mycobacterium tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Sansure Biotech Inc.·1 device

Creatine Kinase-MB Kit (IFCC Method)、CK-MB Calibrator

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

Six Respiratory Pathogens Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Sansure Biotech Inc.·1 device

Group B Streptococcus DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Sansure Biotech Inc.·2 devices

Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Sansure Biotech Inc.·1 device

Hemoglobin A1c Kit (Enzymatic Assay Method)、Hemoglobin A1c calibrator、Hemoglobin A1c control

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·9 devices

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

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

AMPLIRUN® HERPES SIMPLEX 2 DNA CONTROL

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

AMPLIRUN® VARICELLA-ZOSTER VIRUS DNA CONTROL

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

MBC125

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