84 results
·
109ms
·
Sources: EU EUDAMED, US FDA
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ADVIA IMS CPSA CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ADVIA IMS CARBAMAZEPINE METHOD
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TOX AMMONIA CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
ASCENSIA ELITE DIABETES CARE SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CONTOUR NEXT EZ BLOOD GLUCOSE METER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BAYER RAPIDLAB 1200 SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
FDA 510(k)
FDA Class 2
·Neurology
ADVIA 60 HEMATOLOGY ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·CIBA CORNING ACS PSA IMMUNOASSAY
Hepatitis A Test (Antibody And Igm Antibody)
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS