10,000 results · 83ms · Sources: EU EUDAMED, US FDA

VIASPAN (BELZER UW - CSS)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

BCT SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

ACA GENTAMICIN TEST PACK

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

N PROTEIN STANDARD SL

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

KINASE ISOENZYME

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

N PROTEIN STANDARD UY CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

STRATUS CS CKMB CALPAK

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

RCRP FLEX REAGENT CARTRIDGE

FDA 510(k)
FDA Class 2 ·Immunology

BEHRING COAGULATION SYSTEM (BCS)

FDA 510(k)
FDA Class 2 ·Hematology

DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ACA THYROXINE (T4 E) METHOD

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

N LATEX LP(A)

FDA 510(k)
FDA Class 2 ·Immunology

DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ACA TOBRAMY-CIN ANALYTICAL TEST PACK

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Vision

FDA 510(k)
FDA Class 2 ·Dental

ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350

FDA 510(k)
FDA Class 2 ·Clinical Chemistry