170 results · 17ms · Sources: EU EUDAMED, US FDA

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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