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

AK-Calibrant

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.

09120036860025

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.

912003686TC0U00000015X

Reference / catalog number

5010004

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

AK-Calibrant is an in vitro diagnostic calibrator set containing lyophilized human plasma for the calibration of prothrombin time (PT) assays. It is intended for the determination of International Normalized Ratio (INR) and percent of normal, as well as for the establishment of a local International Sensitivity Index (ISI) value when used with validated PT reagents.

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.

• W0103020701CALIBRATION PLASMA FOR HAEMOSTASIS

• IVDR Class C medical devices in EUDAMED

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