10,000 results
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163ms
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Sources: EU EUDAMED, US FDA
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Classification: FDA Class 2
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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