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 DTI

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.

09120036864313

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.

912003686TCBX0000002KZ

Reference / catalog number

5347000

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

Technochrom DTI is an in vitro diagnostic reagent kit for the quantitative determination of direct thrombin inhibitors (DTIs), such as dabigatran, in human sodium-citrated plasma by means of automated, semi-automated, and manual chromogenic methods. It is intended as an aid in the assessment of anticoagulant status in patients receiving therapy with direct thrombin inhibitors.

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.

• W0103020310ANTI IIA ACTIVITY FOT DOAC

• IVDR Class C medical devices in EUDAMED

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