18 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Eu Ivdr
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Qassay Lateral Flow Reader DUAL
Device
EU IVDR
·
Eu Ivd Class A
·P4Q Health S.L.U.·On the market
Qassay Lateral Flow Reader Visible
Device
EU IVDR
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Eu Ivd Class A
·P4Q Health S.L.U.·On the market
iREAD
Device
EU IVDR
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Eu Ivd Class A
·P4Q Health S.L.U.·On the market·32 countries
Qassay Lateral Flow Reader DUAL
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·P4Q Health S.L.U.·2 devices
Q1A-VIS-USB
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·P4Q Health S.L.U.·1 device
Ultra-Low PSA Control (UL PSA Control)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Randox Laboratories Limited·1 device
Total Prostate Specific Antigen(CLIA)、Total PSA Calibrators
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
Access Hybritech PSA (QC)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter Inc.·1 device
Access Hybritech PSA (Calibrator)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter Inc.·1 device
PSA total IRMA KIT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·IMMUNOTECH s.r.o.·1 device
PSA free IRMA KIT
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·IMMUNOTECH s.r.o.·1 device
Access Hybritech free PSA (QC)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter Inc.·1 device
Access Hybritech free PSA (Calibrators)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter Inc.·1 device
Access Hybritech PSA (Sample Diluent)
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·Beckman Coulter Inc.·1 device
Access Hybritech PSA (Reagent Pack)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter Inc.·2 devices
Access Hybritech free PSA (Reagent Pack)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Beckman Coulter Inc.·2 devices
Free Prostate Specific Antigen (CLIA)、Free PSA Calibrators
Basic UDI-DI
EU IVDR
·
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
·
Eu Ivd Class C
·Chemclin Diagnostics Co., Ltd.·4 devices