10,000 results
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54ms
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Sources: EU EUDAMED, US FDA
Verity™
FDA UDI
ST. JUDE MEDICAL, INC.·05414734006835·Pulse Generator DDDR
BS IS-1
FDA UDI
BIOTRONIK SE & Co. KG·04035479144791·
DxI 9000 Access Immunoassay Analyzer
Device
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Inc.·On the market·32 countries
"UniCel DxI Wash Buffer II"
Device
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Inc.·On the market·32 countries
NA
FDA UDI
Amico Diagnostic Incorporated·00697077001513·
NA
FDA UDI
Amico Diagnostic Incorporated·00697077001575·
"UniCel DxI Access Wash Buffer II"
Device
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Inc.·On the market·32 countries
UniCel DxI Immunoassay System Reaction Vessels
Device
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Inc.·On the market·32 countries
UniCel DxI 600 Access Immunoassay System
Device
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Inc.·On the market·32 countries
UniCel DxI 800 Access Immunoassay System
Device
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Inc.·On the market·32 countries
Parallel Bypass, TCA Beckman Unicel DxI 800
FDA UDI
Thermo Fisher Scientific Oy·06438153000587·Parallel Bypass, TCA Beckman Unicel DxI 800 is ...
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH FREE PSA ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
Parallel Bypass, TCA Beckman Unicel DxI 800
Device
EU IVDR
·
Eu Ivd Class A
·Thermo Fisher Scientific Oy·On the market·24 countries
Access AccuTnI+3 on UniCel DxI Calibrators
Device
EU IVDD
·
Eu Ivd General
·Beckman Coulter Inc.·On the market·32 countries
BENCHMARK ELECTRONICS, INC.
FDA registration
BENCHMARK ELECTRONICS, INC.·2 products·🇺🇸 United States
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech PSA
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·Access AFP Reagents on the Access Immunoassay Systems
Dandy Scan Body
FDA UDI
Coremedtech ApS·05744003810284·Dandy Scan body, by CoreMedTech, for dental Int...