Organization name

BIOSYNEX

SRN

FR-MF-000042615

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 14 countries total.

Trade name

IMMUNO-TROL i-Tracker Anti-Adalimumab Total Ab

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.

03532672001520

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.

353267CTA003TPCAZA

Reference / catalog number

CTA 003T-PC

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 B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

IMMUNO-TROL i-Tracker Anti-Adalimumab Total Ab is intended for use as a two-level internal quality control with semi-quantitative assigned values for use in the semi-quantitative detection of total anti-adalimumab antibodies with i-Tracker Anti-Adalimumab Total Ab kit.

Additional information URL

https://edoc.theradiag.com/

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.

• W0102152001TDM/DRUG CONTROLS

• IVDR Class B medical devices in EUDAMED

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