149 results · 23ms · Sources: EU EUDAMED, US FDA

RapidKey COVID-19 Antigen Self Test (25)

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

RapidKey COVID-19 Antigen Self Test (7)

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

MP Diagnostics TP ELISA 4.0

Device
EU IVDD · Eu Ivd General ·MP Biomedicals Asia Pacific Pte Ltd·On the market

MP Diagnostics TP ELISA 4.0

Device
EU IVDD · Eu Ivd General ·MP Biomedicals Asia Pacific Pte Ltd·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

SPOTCHEM D TP

Basic UDI-DI
EU IVDD · Eu Ivd General ·ARKRAY Factory, Inc.·1 device

PT-B (Owren)

Basic UDI-DI
EU IVDD · Eu Ivd General ·TECO Medical Instruments, Production + Trading GmbH·1 device

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