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

SYSMEX MODEL UF1000I

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX UF-50

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

Sysmex UF-5000 Fully Automated Urine Particle Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

939UDX URINE PATHOLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

cobas u 701 microscopy analyzer

FDA 510(k)

FDA Class 2 ·Hematology

iQ200 System, iChemVELOCITY Automated Urine Chemistry System

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE

FDA 510(k)

FDA Class 2 ·Hematology

HEMATOLOGY COMPUTER-INTERFACE, VISCOUNT

FDA 510(k)

FDA Class 2 ·Hematology

SYSMEX UF-100

FDA 510(k)

FDA Class 2 ·Hematology

IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE

FDA 510(k)

FDA Class 2 ·Hematology

IQ 200 SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

AUTION EYE AI-4510 Urine Particle Analysis System

FDA 510(k)

FDA Class 2 ·Hematology

Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

FDA classification

FDA Class 2 ·Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

Counter, Urine Particle

FDA classification

FDA Class 2 ·Counter, Urine Particle

STERIMED STERIZATION WRAPPER (NON-STERILE)

FDA 510(k)

FDA Class 2 ·General Hospital