14 results
·
102ms
·
Sources: EU EUDAMED, US FDA
I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
I-STAT CARDIAC TROPONIN (CTNI) TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
I-STAT KAOLIN ACT TEST
FDA 510(k)
FDA Class 2
·Hematology
I-STAT CREATINE KINASE MB (CK-MB)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
I-STAT PROTHROMBIN TIME TEST
FDA 510(k)
FDA Class 2
·Hematology
Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge
FDA 510(k)
FDA Class 2
·Clinical Chemistry
I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Medical Technology Promedt Consulting GmbH
Authorized representative
🇩🇪 Germany·194 Manufacturers·10009 Devices
JaviTech e.K.
Authorized representative
🇩🇪 Germany·111 Manufacturers·1816 Devices
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices
Mediq Suomi Oy
Importer
🇫🇮 Finland·61 Manufacturers
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices
MedPath GmbH
Authorized representative
🇩🇪 Germany·537 Manufacturers·13464 Devices
SUNGO Europe B.V.
Authorized representative
🇳🇱 Netherlands·1571 Manufacturers·20390 Devices