DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION OF N PROTEIN STANDARD SL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

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

FDA 510(k)

FDA Class 2 ·Hematology

DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

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

CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION TO STANDARD HUMAN PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

SYVA EMIT II PLUS AMPHETAMINES ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DU PONT GENTAMICIN ASSAY REAGENTS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ISOTYPES HUMAN IGG SUBCLASS EIA KIT

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605

FDA 510(k)

FDA Class 2 ·Immunology

DUPONT ACA URINE METHADONE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A

FDA 510(k)

FDA Class 2 ·Clinical Toxicology