36 results
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9ms
·
Sources: EU EUDAMED, US FDA
COMPLEMENT COMPONENT C3/C3C
Device
EU IVDD
·
Eu Ivd General
·Shanghai Kehua Bio-engineering Co., Ltd.·On the market·32 countries
TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER
Device
EU IVDD
·
Eu Ivd General
·Amoy Diagnostics Co., LTD.·On the market
InTec PRODUCTS, INC.
Manufacturer
🇨🇳 China·25 Basic UDI-DIs·25 Devices·2 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH
Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.
Manufacturer
🇨🇳 China·5 Basic UDI-DIs·5 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH
Complement Components C3 Kit (Immunoturbidimetric Assay)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shanghai Kehua Bio-engineering Co., Ltd.·1 device
AmoyDx® KRAS/NRAS Mutations Detection Kit
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Amoy Diagnostics Co., LTD.·1 device
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
HIV MULTIPLE ANTIBODY
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·No longer on the market
HCV ANTIBODY (TOTAL)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·On the market
fPSA Rapid Test
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market
PSA Rapid Test
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market
CancerCheck® PSA
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market
CancerCheck ® fPSA
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.·On the market
ONE STEP Anti-HIV (1&2) Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·1 device
ONE STEP Anti-HIV (1&2) Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·InTec PRODUCTS, INC.·1 device