Simple Simon PT

Primary DI

07333051101109

Basic UDI-DI Code

B-07333051101109

Reference

ZAF-101

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zafena AB

Simple Simon® PT [ZAF-101] – near patient PT INR according to Owren method performed at ambient room temperature Simple Simon® PT measures prothrombin complex (PK) in INR. Simple Simon® PT (SSPT) is intended for in-patient analysis of prothrombin time expressed in INR (PT-INR). The analyte is also called prothrombin complex activity (PK) or tissue factor-induced coagulation time. SSPT is intended for smaller laboratories at hospitals, health centers, medical stations and doctors’ offices. The product can contain ZAF-103 MixxoCap® and has IT support when the product is used with ZAF-552 Zafena POC-Workstation and ZAF-550 Connector. The Simple Simon concept ® is for patient-centered, wet chemical laboratory diagnostics. Simple Simon® is “all-in-one”. Reagents, calibrated reader (measuring unit) and other are in the same product. Reagents and other things have the same lot number and the same expiration date as the reader. Along with each reagent lot comes a factory-controlled, calibrated, “ready-to-use” reader.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).