Device typeCoagulation analyser IVD, home-use, battery-powered: An exclusively battery-powered instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as whole blood prothrombin time (WBPT), whole blood partial thromboplastin time (WBPTT), heparin dose response, activated clotting time (ACT)]; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. It may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry and/or mechanical means of clot formation or end point detection.
FDA categoryTEST, TIME, PROTHROMBIN
Device ID00365702125100
Catalog number04837738001
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information