43 results · 47ms · Sources: EU EUDAMED, US FDA

ADVIA IMS GLUCOSE ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ADVIA IMS LITHIUM ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ADVIA CHEMISTRY TOTAL BILIRUBIN_2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CLINITEST HCG PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

LIPOPROTEIN FOR MULTIPLE ANALYTES

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SETPOINT CHEMISTRY CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC

FDA 510(k)
FDA Class 2 ·Hematology

ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM

FDA 510(k)
FDA Class 2 ·Hematology

CONTOUR NEXT BLOOD GLUCOSE METER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)

FDA 510(k)
FDA Class 2 ·Neurology

MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

LIPOPROTEIN CALIBRATOR

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CLINITEK ADVANTUS, MODEL 1420

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BAYER ADVIA CENTAUR CA 19-9 ASSAY

FDA 510(k)
FDA Class 2 ·Immunology