10,000 results · 92ms · Sources: EU EUDAMED, US FDA

STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION TPSA CALIBRATOR, MODEL #RC459

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)

FDA 510(k)
FDA Class 2 ·Microbiology

CYCLOSPORINE CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Bone Sonometer

FDA Pre-Market Approval
FDA Class 2 ·UBIS 5000 BONE SONOMETER

THYROID CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TROPONIN (TROP) METHOD

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FERRITIN CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MMB CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HUMAN CHORIONIC GONADOTROPIN METHOD

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FERR FLEX REAGENT CARTRIDGE

FDA 510(k)
FDA Class 2 ·Immunology

MMB METHOD

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PROSTATE SPECIFIC ANTIGEN METHOD

FDA 510(k)
FDA Class 2 ·Immunology

PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HUMAN CHORIONIC GONADOTROPIN CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

THYROID STIMULATING HORMONE METHOD

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Bone Sonometer

FDA Pre-Market Approval
FDA Class 2 ·OSTEOSPACE

DATA-TOPE SYSTEM DIGOXIN RIA

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CI-TROL COAGULATION CONTROLS II & III

FDA 510(k)
FDA Class 2 ·Hematology