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.

Great Basin Stool Bacterial Pathogens Panel

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·1 device

Great Basin Bordetella Direct Test

Basic UDI-DI
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·1 device

VitaSIRO solo Instrument

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device

VitaPCR Flu A&B Assay

Basic UDI-DI
EU IVDD · Eu Ivd General ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device

VitaPCR Strep A Assay

Basic UDI-DI
EU IVDD · Eu Ivd General ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device

VitaPCR SARS-CoV-2 Assay

Basic UDI-DI
EU IVDD · Eu Ivd General ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device

VitaPCR SARS-CoV-2 External Control Set

Basic UDI-DI
EU IVDD · Eu Ivd General ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device

VitaPCR SARS-CoV-2 Gen 2 Assay

Basic UDI-DI
EU IVDD · Eu Ivd General ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device

VitaPCR Influenza/SARS-CoV-2 (Flu/SC2) Assay

Basic UDI-DI
EU IVDD · Eu Ivd General ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device

VitaPCR SARS-CoV-2 Gen2 External Control Set

Basic UDI-DI
EU IVDD · Eu Ivd General ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device

VitaPCR RSV External Control Set

Basic UDI-DI
EU IVDD · Eu Ivd General ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device

VitaSIRO solo SARS-CoV-2/Flu/RSV External Control Set

Basic UDI-DI
EU IVDD · Eu Ivd General ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device

VitaSIRO solo SARS-CoV-2/Flu/RSV Assay

Basic UDI-DI
EU IVDD · Eu Ivd General ·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·1 device