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

BIOSYNEX AMPLIFLASH GBS

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

Xpert® GBS

Basic UDI-DI
EU IVDD · Eu Ivd General ·Cepheid·1 device

EasyNAT GBS Assay

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Ustar Biotechnologies (Hangzhou) Ltd.·1 device

EasyNAT GBS Assay

Basic UDI-DI
EU IVDD · Eu Ivd General ·Ustar Biotechnologies (Hangzhou) Ltd.·1 device

Blood Gas Quality Control

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Meizhou Cornley Hi-Tech Co., Ltd.·5 devices

Blood Gas Refill Solution

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Meizhou Cornley Hi-Tech Co., Ltd.·6 devices

Blood Gas Quality Control

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Meizhou Cornley Hi-Tech Co., Ltd.·4 devices

Blood Gas Control Solutions

Basic UDI-DI
EU IVDD · Eu Ivd General ·EAGLENOS SCIENCES, INC.·1 device

Blood Gas Test Cartridges

Basic UDI-DI
EU IVDD · Eu Ivd General ·EAGLENOS SCIENCES, INC.·1 device

Blood Gas/Ion/Metabolite Control

Basic UDI-DI
EU IVDD · Eu Ivd General ·B&E BIO-TECHNOLOGY CO., LTD.·1 device

Tigsun GBS Antigen Rapid Test

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Beijing Tigsun Diagnostics Co., Ltd.·9 devices

Group B Streptococcus (GBS)  Real Time PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·SHANGHAI ZJ BIO-TECH CO., LTD·1 device

Group A Streptococcus (GAS) Real Time PCR Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·SHANGHAI ZJ BIO-TECH CO., LTD·1 device

Electrolyte Analyzer

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·JS Medicina Electrónica SRL·39 devices

Group B Streptococcus (GBS) Nucleic Acid Detection Kit (Fluorescence PCR Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Suzhou TianLong Biotechnology Co., Ltd.·1 device

Group A Streptococcus (GAS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device

Group A Streptococcus (GAS) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Sansure Biotech Inc.·1 device