30 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Kind: Human Tissues
×
Ultra-Low PSA Control (UL PSA Control)
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·Randox Laboratories Limited·1 device
PSA-RIACT
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·Cisbio Bioassays·1 device
HOKAPI™ PSA
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·Suzhou Hokapi Biomedical Engineering Co., Ltd..·1 device
Total Prostate Specific Antigen(CLIA)、Total PSA Calibrators
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
Access Hybritech PSA (QC)
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·Beckman Coulter Inc.·1 device
Access Hybritech PSA (Calibrator)
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·Beckman Coulter Inc.·1 device
Access Hybritech PSA QC
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·Beckman Coulter Inc.·1 device
Access Hybritech free PSA (QC)
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·Beckman Coulter Inc.·1 device
Access Hybritech free PSA (Calibrators)
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·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 Hybritech free PSA Calibrators
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Beckman Coulter Inc.·1 device
CL AIA-PACK PSA ADJUSTER SET
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·Tosoh Corporation·1 device
CL AIA-PACK free PSA ADJUSTER SET
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·Tosoh Corporation·1 device
ST AIA-PACK free PSA CALIBRATOR SET
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·Tosoh Corporation·1 device
Free Prostate Specific Antigen (CLIA)、Free PSA Calibrators
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
Total Prostate Specific Antigen (PSA) (Light-initiated Chemiluminescence Immunoassay, LiCA)
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·Chemclin Diagnostics Co., Ltd.·4 devices
Chemiluminescent Immunoassay Calibrators for Total Prostate Specific Antigen (t-PSA) Calibrators
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·Maccura Biotechnology Co., Ltd. ·1 device
Chemiluminescent Immunoassay Assay Kits for Total Prostate Specific Antigen (f-PSA)
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·Maccura Biotechnology Co., Ltd. ·1 device
Chemiluminescent Immunoassay Assay Kits for Total Prostate Specific Antigen (f-PSA)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Maccura Biotechnology Co., Ltd. ·1 device
Chemiluminescent Immunoassay Assay Kits for Total Prostate Specific Antigen (f-PSA)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Maccura Biotechnology Co., Ltd. ·1 device