604 results · 19ms · Sources: EU EUDAMED, US FDA

Uric Acid T FL

Device
EU IVDR · Eu Ivd Class B ·Chema Diagnostica Srl·On the market·6 countries

DRI Cocaine Metabolite

Device
EU IVDR · Eu Ivd Class B ·Instrumentation Laboratory SpA·On the market·18 countries

CHORUS 25OH VITAMIN D TOTAL

Device
EU IVDR · Eu Ivd Class B ·DIESSE Diagnostica Senese S.p.A·On the market·2 countries

CHORUS ANTI-CCP

Device
EU IVDR · Eu Ivd Class B ·DIESSE Diagnostica Senese S.p.A·On the market·12 countries

SOFTWARE HALO MEASURE & VISUAL

Device
EU IVDR · Eu Ivd Class B ·Copan Wasp S.r.l.·On the market·32 countries

CHORUS ANTI-CCP

Device
EU IVDR · Eu Ivd Class B ·DIESSE Diagnostica Senese S.p.A·On the market·1 country

CHORUS CHIKUNGUNYA IgM

Device
EU IVDR · Eu Ivd Class B ·DIESSE Diagnostica Senese S.p.A·On the market·1 country

Urine MultiDoA Calibrators

Device
EU IVDR · Eu Ivd Class B ·Instrumentation Laboratory SpA·On the market·18 countries

Urine MutiDoA Negative Calibrator

Device
EU IVDR · Eu Ivd Class B ·Instrumentation Laboratory SpA·On the market·18 countries

Calcium Arsenazo

Device
EU IVDR · Eu Ivd Class B ·Instrumentation Laboratory SpA·On the market·18 countries

Urichem Controls

Device
EU IVDR · Eu Ivd Class B ·Instrumentation Laboratory SpA·On the market·18 countries

DRI Opiate

Device
EU IVDR · Eu Ivd Class B ·Instrumentation Laboratory SpA·On the market·18 countries

Creatinine Enzymatic

Device
EU IVDR · Eu Ivd Class B ·Instrumentation Laboratory SpA·On the market·18 countries

EasyNAT Rapid RSV Assay

Device
EU IVDR · Eu Ivd Class B ·Ustar Biotechnologies (Hangzhou) Ltd.·On the market·2 countries

EasyNAT Rapid Flu Assay

Device
EU IVDR · Eu Ivd Class B ·Ustar Biotechnologies (Hangzhou) Ltd.·On the market·2 countries

BioCLIA Autoimmune Reagent Kit dsDNA

Device
EU IVDR · Eu Ivd Class B ·HOB Biotech Group Corp., Ltd.·On the market·3 countries

DermaGenius® 3.0 Nail Multiplex real-time PCR kit

Device
EU IVDR · Eu Ivd Class B ·PathoNostics B.V.·On the market·1 country

ANTI-CENTROMERE ANTIBODIES

Device
EU IVDR · Eu Ivd Class B ·AliveDx Suisse SA·On the market·4 countries

MosaiQ® AiPlex CTD

Device
EU IVDR · Eu Ivd Class B ·AliveDx Suisse SA·On the market·8 countries

iFlash-IgG1

Device
EU IVDR · Eu Ivd Class B ·SHENZHEN YHLO BIOTECH CO., LTD.·On the market·1 country