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

Factor IX DP native

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.

09120036860452

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.

912003686TC490000001QP

Reference / catalog number

5164016

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

FIX deficient plasma is an in vitro diagnostic reagent for the quantitative, WHO-standardized determination of coagulation factor IX (FIX) activity in human sodium-citrated plasma by means of automated, semi-automated, and/or manual coagulometric methods using the activated partial thromboplastin time (APTT)–based one-stage clotting assay. It is intended as an aid in the diagnosis and monitoring of congenital or acquired FIX deficiencies, for clarifying the cause of prolonged APTT, and for monitoring FIX substitution therapy in patients with hemophilia B.

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.

• W0103020208COAGULATION FACTOR IX

• IVDR Class C medical devices in EUDAMED

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