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

not provided

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.

09120036860421

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.

B-09120036860421

Reference / catalog number

5159008

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.

IVDD — General

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

For accuracy control of the determination of Factor VIII Inhibitor according to Bethesda. F VIII Inhibitor Plasma may be used as - a plasma sample of a hemophilia A-patient with F VIII Inhibitor - for accuracy control of the determination of F VIII Inhibitor according to Bethesda (using the reagents of the F VIII Inhibitor Reagent Kit and the reagents for F VIII determination of Technoclone). On the vial label the inhibitor capacity is indicated in Bethesda-Units/mL.

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.

• W0103020702CONTROL PLASMA FOR HAEMOSTASIS

• IVDD — General medical devices in EUDAMED

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