36 results
·
9ms
·
Sources: EU EUDAMED, US FDA
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)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD·1 device
Procalcitonin(CLIA)、PCT Calibrators、PCT Control
Basic UDI-DI
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