ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

FERRITIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INNOVANCE D-DIMER, MODEL OPBP09

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Emit® II Plus Buprenorphine Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISA ENZ 2 CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H

FDA 510(k)

FDA Class 2 ·Immunology

ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LUXAGLAZE

FDA 510(k)

FDA Class 2 ·Dental

DIMENSION C3 FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION AHDL CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LIPASE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Immunology