170 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Eu Ivdd
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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
Sentosa SA C. diff PCR Test v2.0 (4x24)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SA BRAF V600 PCR Test (4x8)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SA BKV PCR Test (4X48)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SA BKV Quantitation Standards (2x13)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SA BKV Quantitation Controls (4x2)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SA BKV PCR Test (4x24)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SA BKV Controls (8x3)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SA BCR-ABL minor Quantitative RT-PCR Test v2.0 (4x8)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SQ Reporter Software
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
VELA Analytics
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Great Basin Group B Streptococcus Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
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
ViroKey Flu A/B & RSV RT-PCR Extension Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SA EBV Quantitation Standards (2x13)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Vela Operations Singapore Pte. Ltd.·1 device