2,731 results
·
37ms
·
Sources: EU EUDAMED, US FDA
SARS-CoV-2 Fluorescent PCR
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
SARS-CoV-2 Fluorescent PCR
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
SARS-CoV-2 Fluorescent PCR
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
Laser, Comb, Hair
FDA classification
FDA Class 2
·Laser, Comb, Hair
DNA/RNA Shield™ SafeCollect Saliva Collection Kit
FDA UDI
Blue Life Solutions, LLC·00860011194507·The DNA/RNA Shield™ SafeCollect Saliva Collecti...
INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01]
Device
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·On the market
INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01]
Device
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·On the market
INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01]
Device
EU IVDD
·
Eu Ivd General
·Hunan Kangxin Biotechnology Co., Ltd.·On the market·32 countries
INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01]
Device
EU IVDD
·
Eu Ivd General
·KH Medical Co., Ltd.·On the market
Over-The-Counter Covid-19 Antigen Test
FDA classification
FDA Class 2
·Over-The-Counter Covid-19 Antigen Test
BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel
FDA UDI
BIOFIRE DIAGNOSTICS, LLC·00815381020659·IVD reagent kit containing 30 tests.
Covid-19 Test Home Collection Kit Devices
FDA classification
FDA Not Classified
·Covid-19 Test Home Collection Kit Devices
SARS-CoV-2 Antigen Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Alltest Biotech.Co.,Ltd.·1 device
SARS-CoV-2 Ag Duo Home
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Nantong EgensBiotechnology Co.,Ltd.·1 device
SARS-CoV-2 Antigen Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Nantong EgensBiotechnology Co.,Ltd.·1 device
MERS-CoV Real Time PCR Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device
MERS-CoV Real Time PCR Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device
SARS-CoV Real Time PCR Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device
SARS-CoV Real Time PCR Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Jiangsu Bioperfectus Technologies Co., Ltd.·1 device
SARS-CoV-2 Antigen Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Hangzhou Alltest Biotech.Co.,Ltd.·1 device