2,983 results · 42ms · Sources: EU EUDAMED, US FDA

OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CRITIC C LEVEL I & II

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE)

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

OXALATE URINE CONTROLS (NORMAL AND ELEVATED)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ALCOHOL & AMMONIA CALIBRATOR I

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

RANDOX ALDOLASE CALIBRATION SERUM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

IMMUSURE

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DC LIQUITROL LEVEL 1 & 2

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

AUDIT MICROCV IMMUNOASSAY LINEARITY SET

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

G-GT STANDARD CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

NEFA STANDARD SOLUTION CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PATHFAST CK-MB-II CALIBRATORS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

NORMAL UNASSAYED CONTROL SERA

FDA 510(k)
FDA Class 1 ·Clinical Chemistry