DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROSTREP PLUS PANEL, AZITHROMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

N APOLIPOPROTEIN STANDARD SERUM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CONTROL PLASMA N AND CONTROL PLASMA P

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Immunology

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

DRIED GRAM-NEGATIVE MIC/COMBO PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

DADE BEHRING N HIGH SENSITIVITY CRP ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION C4 FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML)

FDA 510(k)

FDA Class 2 ·Microbiology

DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION OF N PROTEIN STANDARD SL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK

FDA 510(k)

FDA Class 2 ·Hematology

N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN

FDA 510(k)

FDA Class 2 ·Immunology

STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME

FDA 510(k)

FDA Class 2 ·Microbiology

DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROSCAN SYNERGIES PLUS

FDA 510(k)

FDA Class 2 ·Microbiology