Monkeypox Virus（MPxV）IgM/IgG Rapid Detection Kit （Immunochromatography Assay）

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·1 device

COVID-19 Ag and IgG/IgM Ab Combo Rapid Test

Basic UDI-DI

EU IVDD · Eu Ivd General ·W.H.P.M. Bioresearch & Technology Co., Ltd.·1 device

ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·1 device

ONE STEP Dengue IgG/IgM - NS1 Combo Test (Colloidal Gold)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·1 device

Dengue NS1 Antigen, IgM/IgG Antibody Dual Detection Kit (Immunochromatography)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·1 device

Dengue NS1 Antigen, IgM/IgG Antibody Dual Detection Kit (Immunochromatography)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.·1 device

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM

Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents

FDA classification

FDA Not Classified ·Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents

Anaplasma Spp. And Ehrlichia Spp. Serological Reagents

FDA classification

FDA Not Classified ·Anaplasma Spp. And Ehrlichia Spp. Serological Reagents

Anti-S, for card method monoclonal, human IgM clone: MS-94

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·ANTITOXIN GmbH·1 device

Anti-Cw, for card method monoclonal, human IgM clone: MS-110

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·ANTITOXIN GmbH·1 device

Rapid Dengue NS1 Antigen and IgG/IgM Duo Panel Test Card

Basic UDI-DI

EU IVDD · Eu Ivd General ·Xiamen Boson Biotech Co., Ltd.·1 device

Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit

Basic UDI-DI

EU IVDD · Eu Ivd General ·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device

Anti-Jkb for card method, monoclonal, human IgM clone: MS-8

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·ANTITOXIN GmbH·1 device

Anti-Jka for card method, monoclonal, human IgM clone: MS-15

Basic UDI-DI

EU IVDD · Eu Ivd Annex 2 List B ·ANTITOXIN GmbH·1 device

Herpes Simplex Virus HSV1/2 IgG/IgM Rapid Test Cat.No.:HHSV074T

Basic UDI-DI

EU IVDD · Eu Ivd General ·Hangzhou Immuno Biotech Co., Ltd·1 device

Monkeypox Virus IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Zhejiang Wantaifu Biotechnology Co., Ltd·1 device