DADE BEHRING N HIGH SENSITIVITY CRP ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

DUPONT DRUG CLIBRATOR-B

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION C4 FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

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

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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

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