REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application

FDA 510(k)

FDA Class 2 ·Hematology

ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)

FDA 510(k)

FDA Class 2 ·Hematology

AGGRECETIN

FDA 510(k)

FDA Class 2 ·Hematology

DMA GLUCOSE (OXIDASE) PROCEDURE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NAPHTHYL PHOSPHATE, ACID PHOSPHATASE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BILIRUBIN (TOTAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ADVIA 2120/2120I BODY FLUIDS

FDA 510(k)

FDA Class 2 ·Hematology

Aegis Transit System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls

FDA 510(k)

FDA Class 2 ·Hematology

TULA Tube Delivery System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

MultiSure GK Link Blood Glucose and Ketone Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LARYNGEAL STENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

THYROXINE-BINDING GLOBULIN RADIOUMMU

FDA 510(k)

FDA Class 2 ·Clinical Chemistry