21 results · 13ms · Sources: EU EUDAMED, US FDA

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HIV 1 / 2 - RT & POC

Device
EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·On the market

ViroKey SARS-CoV-2 RT-PCR Test

Device
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·On the market

SARS-CoV-2 RT-qPCR Reagent kit

Device
EU IVDD · Eu Ivd General ·Wallac Oy·On the market·32 countries

SARS-CoV-2 RT-PCR Test Kit

Device
EU IVDD · Eu Ivd General ·MedicalSystem Biotechnology Co., Ltd.·On the market

ViroKey SARS-CoV-2 RT-PCR Test v2.0 (4x96)

Device
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·On the market

ViroKey SARS-CoV-2 RT-PCR Test v2.0 (8x48)

Device
EU IVDD · Eu Ivd General ·Vela Operations Singapore Pte. Ltd.·On the market

PKamp Respiratory SARS-CoV-2 RT-PCR Panel kit

Device
EU IVDD · Eu Ivd General ·Wallac Oy·No longer on the market·32 countries

PKamp Respiratory SARS-CoV-2 RT-PCR Panel kit

Device
EU IVDD · Eu Ivd General ·Wallac Oy·On the market·32 countries

HCV ANTIBODY -RT & POC

Device
EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·On the market

HBSAG - RT & POC

Device
EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·On the market

Allergen Discs Art v 1 (Beifuß)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Gold Standard Diagnostics Kassel GmbH·1 device

ViroKey SARS-CoV-2 RT-PCR Test

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

SARS-CoV-2 RT-PCR Test Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·MedicalSystem Biotechnology Co., Ltd.·1 device

SARS-CoV-2 RT-qPCR Reagent kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Wallac Oy·1 device

RespiDetect Respiratory Panel 1 RT-qPCR Assay

Basic UDI-DI
EU IVDD · Eu Ivd General ·PentaBase A/S·1 device

PKamp Respiratory SARS-CoV-2 RT-PCR Panel kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Wallac Oy·1 device

ViroKey SARS-CoV-2 RT-PCR Test v2.0 (4x96)

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

ViroKey SARS-CoV-2 RT-PCR Test v2.0 (8x48)

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

PKamp Respiratory SARS-CoV-2 RT-PCR Panel kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Wallac Oy·1 device

HCV Hepatitis C Virus Rapid Test Device (Serum/Plasma)

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·1 device