462 results · 63ms · Sources: EU EUDAMED, US FDA
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LYPHOCHEK WHOLE BLOOD CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST

FDA 510(k)
FDA Class 2 ·Hematology

DETER. OF HEMOGLOBIN A2 USING THE DIAMAT

FDA 510(k)
FDA Class 2 ·Hematology

LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

NOVAPATH TSH ENZYME IMMUNOASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

DIGILAB 350 THE KRAKAU PERIMETER

FDA 510(k)
FDA Class 1 ·Ophthalmic

LIQUICHEK CARDIAC MARKERS CONTROL LT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

QUANTA PHASE VITAMIN B-12/FOLATE RAD

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BIOGRAM APO A1/B

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

TRIGLYCERIDES GPO REAGENT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LIQUICHEK CK/LD ISOENZYME CONTROL; LEVELS 1 AND 2

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MANUAL PHENYLALANINE TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

ARCHITECH AFP MASTERCHECK, MODEL 6C01-05

FDA 510(k)
FDA Class 1 ·Clinical Chemistry