BEHRING COAGULATION SYSTEM (BCS)

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACA THYROXINE (T4 E) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

N LATEX LP(A)

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACA TOBRAMY-CIN ANALYTICAL TEST PACK

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Vision

FDA 510(k)

FDA Class 2 ·Dental

ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DADE BEHRING COAGULATION ANALYZER (BCT)

FDA 510(k)

FDA Class 2 ·Hematology

EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR

FDA 510(k)

FDA Class 2 ·Immunology

VivaChek Ino Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TROPONIN (TROP) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION ALDL CALIBRATOR, MODEL DC131

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426

FDA 510(k)

FDA Class 2 ·Immunology