2,138 results · 47ms · Sources: EU EUDAMED, US FDA

ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ELECSYS PROBNP II CALCHECK 5

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12 RANGE VERIFIERS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

WAKO NEFA LINEARITY SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SERACON CR REFERENCE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HEMOCUE GLUCOLIN

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

TNT TROPONIN T

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DADE TRU-LIQUID BILIRUBIN CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

CHEMSPEX(TM) AMMONIA CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3

FDA 510(k)
FDA Class 1 ·Clinical Chemistry