2,418 results · 42ms · Sources: EU EUDAMED, US FDA

TRUPCR® Total Viral Nucleic Acid Extraction Kit (500µl)

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·3B BlackBio Dx Limited·1 device

TRUPCR® BS DNA Extraction Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·3B BlackBio Dx Limited·1 device

TRUPCR® Panel Extraction Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·3B BlackBio Dx Limited·1 device

TRUPCR® BS DNA Extraction Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·3B BlackBio Dx Limited·1 device

TRUPCR® Total Viral Nucleic Acid Extraction Kit (500ul)

Basic UDI-DI
EU IVDD · Eu Ivd General ·3B BlackBio Dx Limited·1 device

Ldl & Vldl Precipitation, Hdl

FDA classification
FDA Class 1 ·Ldl & Vldl Precipitation, Hdl

HD 60144656

Certificate
MDD Annex II (excluding section 4)·Substrate HD·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·CRCDx RAS Mutation Detection Assay Kit

Plasminogen, Antigen, Antiserum, Control

FDA classification
FDA Class 1 ·Plasminogen, Antigen, Antiserum, Control

Radioimmunoassay, Total Thyroxine

FDA classification
FDA Class 2 ·Radioimmunoassay, Total Thyroxine

Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl

FDA classification
FDA Class 1 ·Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl

Dimension GGT Flex

FDA registration
SIEMENS HEALTHCARE DIAGNOSTICS INC.·11 products·🇺🇸 United States

Determine HIV Early Detect

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Abbott Diagnostics Medical Co., Ltd.·1 device

EDTA Capillary Tubes

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Abbott Diagnostics Medical Co., Ltd.·1 device

Determine HIV Controls

Basic UDI-DI
EU IVDD · Eu Ivd Annex 2 List A ·Abbott Diagnostics Medical Co., Ltd.·1 device

Chase Buffer

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Abbott Diagnostics Medical Co., Ltd.·1 device

Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

FDA classification
FDA Class 2 ·Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

Lipoprotein, High Density, Hdl, Over The Counter

FDA classification
FDA Class 1 ·Lipoprotein, High Density, Hdl, Over The Counter

Colposcope (And Colpomicroscope), Exempt

FDA classification
FDA Class 2 ·Colposcope (And Colpomicroscope), Exempt

Tenaculum, Uterine, Exempt

FDA classification
FDA Class 2 ·Tenaculum, Uterine, Exempt