AUTION EYE AI-4510 Urine Particle Analysis System

FDA 510(k)

FDA Class 2 ·Hematology

PRIMUS A1CARE ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

SIGMA PROCEDURE #890

FDA 510(k)

FDA Class 2 ·Hematology

ARIOL HER-2/NEU IHC

FDA 510(k)

FDA Class 2 ·Hematology

FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link)

FDA 510(k)

FDA Class 2 ·Hematology

THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY

FDA 510(k)

FDA Class 2 ·Hematology

VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU

FDA 510(k)

FDA Class 2 ·Hematology

PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

CONTROL DIAGNOSTICS PLATELET CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

A1c iGear System

FDA 510(k)

FDA Class 2 ·Hematology

VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)

FDA 510(k)

FDA Class 2 ·Hematology

GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION

FDA 510(k)

FDA Class 2 ·Hematology

DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT

FDA 510(k)

FDA Class 2 ·Hematology

XPERT HEMOSIL FACTOR II & FACTOR V ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

HEMOCUE HBA1C 501

FDA 510(k)

FDA Class 2 ·Hematology

BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK

FDA 510(k)

FDA Class 2 ·Hematology

RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA

FDA 510(k)

FDA Class 2 ·Hematology

CYTOSCAN

FDA 510(k)

FDA Class 2 ·Hematology

Test, Time, Prothrombin

FDA classification

FDA Class 2 ·Test, Time, Prothrombin

Assay, Glutathione Reductase

FDA classification

FDA Class 2 ·Assay, Glutathione Reductase