Organization name

Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH

SRN

AT-MF-000024115

Manufacturer status

Active

Primary placement in Austria; available across 32 countries total.

Trade name

Technochrom anti-Xa

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

09120036862715

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

912003686TC080000001M8

Reference / catalog number

5340250

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The Technochrom anti-Xa is an in vitro diagnostic reagent kit for the quantitative determination of direct factor Xa (FXa) inhibitors in human sodium citrated plasma by means of semi-automated or automateted chromogenic methods. Direct FXa inhibitor determination is intended as an aid in the management of direct FXa inhibitor based anticoagulant therapy. In addition, the Technochrom anti-Xa assay can be used for WHO standardized determination of heparin activity and other indirect FXa inhibitors for monitoring patients under heparin or heparinoid therapy. The choice of the respective calibrator defines the validated analyte- or drug-specific application of the assay.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• W0103020309ANTI XA ACTIVITY FOR HEPARIN AND DOAC

• IVDR Class C medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.