2,138 results · 44ms · Sources: EU EUDAMED, US FDA

CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ABX PENTRA 400: LIPOPROTEINS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TOTAL BILIRUBIN STANDARD CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

RESPONSE LIQUID LIGAND ASSAY SERUM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CALIBRATING MATERIAL, CALIBRATING STANDARDS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ELECSYS PRECICONTROL VARIA 3

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACCURUN 117 HBEAG POSITIVE CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

IT/IF CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CHOLESTEROL CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

QUEST TUMOR MARKER CONTROL, MODEL 955

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

Elecsys Estradiol III CalSet

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VIGIL SEROLOGY CONTROL LEVEL C

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry