1,060 results
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11ms
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Sources: EU EUDAMED, US FDA
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
Detection Kit for 5 Mutations of SARS-CoV-2 (PCR-Fluorescence Probing)
Device
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·On the market
Detection Kit for 5 Mutations of SARS-CoV-2 (PCR-Fluorescence Probing)
Device
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·On the market
Xiamen Biotime Biotechnology Co., Ltd.
Manufacturer
🇨🇳 China·399 Basic UDI-DIs·401 Devices
Genrui Biotech Inc.
Manufacturer
🇨🇳 China·116 Basic UDI-DIs·134 Devices
MB isoenzyme of creatine kinase Assay Kit (Chemiluminescent Immunoassay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
MB isoenzyme of creatine kinase Assay Kit (Chemiluminescent Immunoassay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
Detection Kit for 5 Mutations of SARS-CoV-2 (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
Detection Kit for 5 Mutations of SARS-CoV-2 (PCR-Fluorescence Probing)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sansure Biotech Inc.·1 device
BIOTIME
Device
EU IVDR
·
Eu Ivd Class A
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
Device
EU IVDR
·
Eu Ivd Class A
·Genrui Biotech Inc.·On the market
FIA Analyzer BIOT-YG-I
Device
EU IVDR
·
Eu Ivd Class A
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
FIA Analyzer FLI-110
Device
EU IVDR
·
Eu Ivd Class A
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
FIA Analyzer FLI-100
Device
EU IVDR
·
Eu Ivd Class A
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
Total IgE Rapid Quantitative Test
Device
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
CRP/SAA Rapid Quantitative Test
Device
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
BIOTIME
Device
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
BIOTIME
Device
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
BIOTIME
Device
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·On the market