1,816 results
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32ms
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Sources: EU EUDAMED, US FDA
Access Hybritech free PSA (QC)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter Inc.·1 device
Access Intrinsic Factor Ab QC
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Beckman Coulter Inc.·1 device
Access sTfR QC (level 1)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Beckman Coulter Inc.·1 device
Access Toxo IgM II QC
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Beckman Coulter Inc.·1 device
Access Hybritech free PSA QC
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Beckman Coulter Inc.·1 device
Access Intrinsic Factor Antibody QC
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Beckman Coulter Inc.·1 device
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA Centaur HBsAgII (HBsII) and ADVIA Centaur HBsAgII Confirmatory (HBsII Conf) Assay
STA® - Routine QC 2 ml
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Diagnostica Stago·1 device
ACCESS SARS-CoV-2 IgM QC
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Beckman Coulter Inc.·1 device
Access SARS-CoV-2 IgG QC
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Beckman Coulter Inc.·1 device
Assayed Multiple Chemistry Control (Multi-QC)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
Assayed Multiple Chemistry Control (Multi-QC)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·1 device
Assayed Multiple Chemistry Control (Multi-QC)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Maccura Biotechnology Co., Ltd. ·2 devices
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Atellica IM Hepatitis B e Antigen (HBeAg)
LensHooke® X QC Slide (For Semen)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Bonraybio Co., LTD.·1 device
Access sTfR QC (levels 2 & 3)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Beckman Coulter Inc.·1 device
LensHooke® X QC Video (For Semen)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Bonraybio Co., LTD.·4 devices
LensHooke® X QC Reticle (For Semen)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Bonraybio Co., LTD.·4 devices
LensHooke® X QC Beads (For Semen)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Bonraybio Co., LTD.·1 device
Access SARS-CoV-2 IgG II QC
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Beckman Coulter Inc.·1 device