3,678 results
·
60ms
·
Sources: EU EUDAMED, US FDA
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
CONTREX PLUS LOW CONTROL SOLUTION
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DAC-CEL DIAGNATAL HCG STANDARDS RD49
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LD-1 ISOENZYME CONTROL (HUMAN) LEVEL 1 & 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Multichem A1c
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry