Organization name

Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH

SRN

AT-MF-000024115

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Component 2 (Technoclot PT Plus Solvent) contains Nickel Sulphate. May cause allergic reactions.

  OTHER

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.

09120036862708

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-09120036862708

Reference / catalog number

5003222

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 PT Plus is used for the determination of the prothrombin time (Quick test). This screening test is used - for the control of blood coagulation disorders of the extrinsic system, - for the surveillance of oral anticoagulant therapy, - for separate determination of individual coagulation factors of the extrinsic system, - to check the liver’s function of synthesizing coagulation factors in hepatopathies. A heparin neutralizing agent in the reagent permits the assessment of plasma obtained from patients on conventional heparin therapy (1 - 2 U. hep./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.

• W0103020101PROTHROMBIN TIME ( QUICK TEST )

• IVDD — General medical devices in EUDAMED

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