Trinity Biotech

FDA UDI

MARDX DIAGNOSTICS, INC.·05391516748728·Liver (IgG) Marblot Strip Test System, Western ...

QUANTA Flash® LKM-1 Reagents

FDA UDI

INOVA DIAGNOSTICS, INC.·08426950767008·1. QUANTA Flash LKM-1 reagent cartridge contain...

iQ®200

FDA UDI

IRIS INTERNATIONAL, INC.·10837461002192·iQ® Lamina™ Cradle

Fully Automated Urine Particle Analyzer UF-1000i

FDA UDI

SYSMEX CORPORATION·04987562408542·Sysmex UF-1000i™ Automated Urine Particle Analyzer

Fully Automated Urine Particle Analyzer UF-5000

FDA UDI

SYSMEX CORPORATION·04987562440139·Fully Automated Urine Particle Analyzer UF-5000

Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software

FDA UDI

Sysmex America, Inc.·00664369000639·Fully Automated Urine Cell Analyzer UF-1000i UF...

QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls

FDA 510(k)

FDA Class 2 ·Immunology

QUANTA LITE LKM-1 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

EUROIMMUN ANTI-LKM-1 ELISA(LGG)

FDA 510(k)

FDA Class 2 ·Immunology

CA 20:1 L KM

Device

EU MDR · Eu Md Class 2a ·Bien-Air Dental SA·On the market·31 countries

Urine Analyzer

FDA registration

Diamond Diagnostics Inc.·2 products·🇭🇺 Hungary

iQ200 Sprint Automated Urine Microscopy Analyzer (800-3053; 800-3933; 800-3053; 800-3933)

FDA registration

BECKMAN COULTER, INC.·2 products·🇺🇸 United States

iQ200 Sprint Automated Urine Microscopy Analyzer (800-3053; 800-3933; 800-3053; 800-3933)

FDA registration

BECKMAN COULTER, INC.·2 products·🇺🇸 United States

AUTION EYE AI-4510

FDA registration

ARKRAY FACTORY USA, INC.·2 products·🇺🇸 United States

AUTION EYE AI-4510

FDA registration

ARKRAY, INC.·2 products·🇯🇵 Japan

AUTION EYE AI-4510

FDA registration

ARKRAY Factory, Inc.·2 products·🇯🇵 Japan

CA 20:1 L KM

FDA UDI

Bien-Air Dental SA·J00716007850011·CA and HP are intended to transmit and apply th...

Sharay Anti-LKM-1 IgG (CLIA)

Device

EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·No longer on the market

CA 20:1 LKM Micro-Series

Device

EU MDR · Eu Md Class 2a ·Bien-Air Dental SA·On the market·31 countries

BioCLIA Autoimmune Control Set, LKM-1

Device

EU IVDD · Eu Ivd General ·HOB Biotech Group Corp., Ltd.·On the market