Analyser, point-of-care (POC), PT/INR

Alternative names
Analyzer, prothrombin time
Type of medical device or related product
General vs. specific use (health condition)
Intended population sex
Level of technical knowledge
Capital
Reusable
Requirements
None
WHO list of priority medical devices
EMDN related code(s)
W0103020801
PROTHROMBIN TIME RT & POC
GMDN related code(s)
62540
Coagulation analyser IVD, point-of-care, line-powered (A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used exclusively at the point-of-care by medical professionals 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 may include spectrophotometry, turbidimetry, nephelometry, electrometry, electromagnetic and/or mechanical means of clot formation or end point detection.)