Organization name

Diagnostic Grifols, S.A.

SRN

ES-MF-000000784

Manufacturer status

Active

Primary placement in Spain; available across 32 countries total.

Trade name

Anti-Leb Mono-Type

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.

08436583731550

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.

843658373ANTISERA013GU

Reference / catalog number

210928

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

The Anti-Leb Mono-Type monoclonal murine IgA blood grouping reagent is used in a qualitative test method to determine the presence or absence of the Leb (LE2) antigen on the surface of human red blood cells. This reagent is intended to be used for ensuring the immunological compatibility of blood and blood components that are intended for transfusion. For use in conventional tube technique.

Additional information URL

https://techdocs.grifols.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.

• W0103030501OTHER ANTIGEN TYPING REAGENTS

• IVDR Class C medical devices in EUDAMED

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