10,000 results · 163ms · Sources: EU EUDAMED, US FDA

ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ACCU-CHEK SIMPLICITY SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

AXSYM ULTRASENSITIVE HTSH

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DCA 2000 SYSTEM FOR HEMOGLOBIN A1C

FDA 510(k)
FDA Class 2 ·Hematology

D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM

FDA 510(k)
FDA Class 2 ·Hematology

TSH-STAT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

FDA 510(k)
FDA Class 2 ·Immunology

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CEA DESALTING DOLUMN SEPHADEX R

FDA 510(k)
FDA Class 2 ·Immunology

VACUETTE EVACUATED BLOOD COLLECTION TUBES

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

LIASYS WITH MODELS LIASYS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

WUNDER PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry