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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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

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

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

MP Diagnostics HBsAg ELISA 4.1

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·MP Biomedicals Asia Pacific Pte Ltd·1 device

MP Diagnostics HBsAg ELISA 4.1

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·MP Biomedicals Asia Pacific Pte Ltd·1 device

MP Diagnostics HCV ELISA 4.0

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·MP Biomedicals Asia Pacific Pte Ltd·1 device

MP Diagnostics HCV ELISA 4.0

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·MP Biomedicals Asia Pacific Pte Ltd·1 device

MP Diagnostics HIV Ag/Ab Combo ELISA 4.0

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·MP Biomedicals Asia Pacific Pte Ltd·1 device

MP Diagnostics HIV Ag/Ab Combo ELISA 4.0

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·MP Biomedicals Asia Pacific Pte Ltd·1 device