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.

09120036862197

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-09120036862197

Reference / catalog number

5343012

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

TECHNOCLOT LA Screen and TECHNOCLOT LA Confirm are simplified DRVVT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests. TECHNOCLOT LA Screen is a simplified DRVV reagent to screen for the presence of Lupus Anticoagulants. TECHNOCLOT LA Confirm is a phospholipids rich DRVV reagent for the specific correction of Lupus Anticoagulants. LAs are auto antibodies against negatively charged phospholipids or complexes of phospholipids with either beta-2-glycoprotein 1 or clotting factors such as prothrombin. They occur in various clinical conditions, especially autoimmune diseases and are now considered to be a significant risk factor in patients with otherwise unexplained thrombosis and are often present in women who have recurrent foetal loss. LA have traditionally been detected using phospholipid responsive clotting tests, such as the activated partial thromboplastin time (aPTT), kaolin clotting time (KCT) and DRVVT where they have an anticoagulant effect.

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.

• W0103020606LUPUS ANTICOAGULANT

• IVDD — General medical devices in EUDAMED

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