ZAF-101

Organization name

Zafena AB

SRN

SE-MF-000024138

Manufacturer status

Active

Primary placement in Sweden; available across 4 countries total.

Trade name

not provided

UDI-DI code

07333051101109

Basic UDI-DI

B-07333051101109

Reference / catalog number

ZAF-101

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

https://www.zafena.se/product/zafena-101-simple-simon-pt/

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0103020801PROTHROMBIN TIME RT & POC

This device is not currently linked to any other device.