26 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Eu Ivdr
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Discs for antimicrobial susceptibility testing Cefpirome, CFP, 30mcg
Device
EU IVDR
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Eu Ivd Class A
·Tody Laboratories Med SRL·On the market
AFP Calibrators
Device
EU IVDR
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Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·On the market·2 countries
AFP CLIA Microparticles
Device
EU IVDR
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Eu Ivd Class C
·Autobio Diagnostics Co., Ltd.·On the market·3 countries
AFP CLIA Microparticles
Device
EU IVDR
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Eu Ivd Class C
·Autobio Diagnostics Co., Ltd.·On the market·3 countries
Access AFP (Calibrators)
Device
EU IVDR
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Eu Ivd Class C
·Beckman Coulter Inc.·On the market·32 countries
AFP IRMA KIT
Device
EU IVDR
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Eu Ivd Class C
·IMMUNOTECH s.r.o.·On the market·17 countries
Access AFP Sample Diluent
Device
EU IVDR
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Eu Ivd Class C
·Beckman Coulter Inc.·On the market·32 countries
AFP screening IRMA KIT
Device
EU IVDR
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Eu Ivd Class C
·IMMUNOTECH s.r.o.·On the market·12 countries
Access AFP (300 & 600 Test Kit)
Device
EU IVDR
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Eu Ivd Class C
·Beckman Coulter Inc.·On the market·32 countries
Access AFP (300 & 600 Test Kit)
Device
EU IVDR
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Eu Ivd Class C
·Beckman Coulter Inc.·On the market·32 countries
AFP RAPID TEST CASSETTE (WHOLE BLOOD/SERUM/PLASMA)
Device
EU IVDR
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Eu Ivd Class A
·Tody Laboratories Int. SRL·On the market
Alpha-fetoprotein （AFP）Assay Kit (Chemiluminescent Microparticle Immunoassay)
Device
EU IVDR
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Eu Ivd Class C
·URIT Medical Electronic Co.,Ltd.·On the market·1 country
Access AFP (100 & 200 Test)(Reagent Pack)
Device
EU IVDR
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Eu Ivd Class C
·Beckman Coulter Inc.·On the market·32 countries
Access AFP (100 & 200 Test)(Reagent Pack)
Device
EU IVDR
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Eu Ivd Class C
·Beckman Coulter Inc.·On the market·32 countries
Freezing embedding medium
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·WellMed BV·1 device
Alpha-1-Fetoprotein (AFP); Polyclonal (Ready-To-Use) 25 mL
Device
EU IVDR
·
Eu Ivd Class C
·ScyTek Laboratories Inc.·On the market·1 country
Alpha-1-Fetoprotein (AFP); Polyclonal (Ready-To-Use) 7 mL
Device
EU IVDR
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Eu Ivd Class C
·ScyTek Laboratories Inc.·On the market·1 country
Access AFP (Calibrators)
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·Beckman Coulter Inc.·1 device
AFP IRMA KIT
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·IMMUNOTECH s.r.o.·1 device
High Sensitivity C-reactive Protein Kit（Particle-enhanced Immunoturbidimetric Assay Method）、HS-CRP Calibrator
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·7 devices