Organization name

QUIMICA CLINICA APLICADA S.A.

SRN

ES-MF-000001512

Manufacturer status

Active

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

• Consult instructions for use

Primary placement in Spain; available across 32 countries total.

Trade name

RF DIRECT LATEX

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.

18430155003417

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-18430155003417

Reference / catalog number

994521

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

The device RF Direct Latex is an in vitro diagnostic medical device intended to be used by professional users for the qualitative and semi-quantitative determination of rheumatoid factors in human serum samples using the slide agglutination test. The measurement of rheumatoid factors contributes to the diagnosis of rheumatoid arthritis in the general population.

Additional information URL

https://qca.es/es/

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.

• W01021110RHEUMATOID FACTORS

• IVDD — General medical devices in EUDAMED

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