116 results
·
7ms
·
Sources: EU EUDAMED, US FDA
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