10,000 results · 54ms · 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...