ACA URINE BENZODIAZEPINES (UBENZ) SCREEN METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DU PONT MAMMOGRAPHY CASSETTE

FDA 510(k)

FDA Class 2 ·Radiology

DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604

FDA 510(k)

FDA Class 2 ·Immunology

Atellica® CH Diazo Direct Bilirubin (D_DBil)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COBES SURGICAL DRAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ADVANCED D-DIMER

FDA 510(k)

FDA Class 2 ·Hematology

BentrioTM Allergy Blocker

FDA 510(k)

FDA Class 2 ·General Hospital

DIMENSIONS HB1C KIT, MODEL DF105A

FDA 510(k)

FDA Class 2 ·Hematology

OPUS TROPONIN I CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACA(R) DIGITOXIN (DGTX) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

N PROTEIN STANDARD UY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PAROJECT ANESTHETIC SYRINGE

FDA 510(k)

FDA Class 2 ·Dental

ADVANCED D-DIMER ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA

FDA 510(k)

FDA Class 2 ·Immunology