25 results
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9ms
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Sources: EU EUDAMED, US FDA
VitaSIRO solo Instrument
Device
EU IVDR
·
Eu Ivd Class A
·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·On the market
VitaPCR Flu A&B Assay
Device
EU IVDD
·
Eu Ivd General
·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·On the market
VitaPCR Strep A
Device
EU IVDD
·
Eu Ivd General
·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·On the market
VitaPCR SARS-CoV-2 Assay
Device
EU IVDD
·
Eu Ivd General
·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·On the market
VitaPCR SARS-CoV-2 External Control Set
Device
EU IVDD
·
Eu Ivd General
·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·On the market
VitaPCR SARS-CoV-2 Gen 2 Assay
Device
EU IVDD
·
Eu Ivd General
·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·On the market
VitaPCR Influenza/SARS-CoV-2 (Flu/SC2) Assay
Device
EU IVDD
·
Eu Ivd General
·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·On the market
VitaPCR SARS-CoV-2 Gen 2 External Control Set
Device
EU IVDD
·
Eu Ivd General
·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·On the market
VitaPCR RSV External Control Set
Device
EU IVDD
·
Eu Ivd General
·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·On the market
VitaSIRO solo SARS-CoV-2/Flu/RSV External Control Set
Device
EU IVDD
·
Eu Ivd General
·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·On the market
VitaSIRO solo SARS-CoV-2/Flu/RSV Assay
Device
EU IVDD
·
Eu Ivd General
·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·On the market
VitaPCR Instrument
Device
EU IVDR
·
Eu Ivd Class A
·Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch ·On the market
546003 MR5
Certificate
MDD Annex V·Livac Pty Ltd·DQS Medizinprodukte GmbH·2 Basic UDI-DIs
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