13 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.

Aspartate Aminotransferase Kit (UV-MDH Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·1 device

Diluent-2

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Human Gesellschaft für Biochemica und Diagnostica mbH·1 device

Diluent

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Human Gesellschaft für Biochemica und Diagnostica mbH·1 device

PoET Master Positive Control

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH·1 device

PoET Extraction

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH·1 device

PoET Internal Control

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH·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

MP Diagnostics TP ELISA 4.0

Basic UDI-DI
EU IVDD · Eu Ivd General ·MP Biomedicals Asia Pacific Pte Ltd·1 device