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.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Spain; available across 32 countries total.

Trade name

APOLIPOPROTEIN CALIBRATOR

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.

18430155009013

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-18430155009013

Reference / catalog number

993690

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 Apolipoprotein Calibrator is an in vitro diagnostic medical device intended to be used by professional users as a calibrator in quantitative immunoturbidimetric assays for the determination of apolipoproteins in human serum or plasma samples. Its determination establishes the quantitative relationship between the signal measured by the analytical system and the concentration of the analyte of interest, and it is used to generate the calibration curve required for the quantitative determination of the analyte in human samples. The use of the calibrator ensures the accuracy, precision, and metrological traceability of the results obtained with the associated reagents.

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.

• W0102152203SPECIFIC PROTEIN STANDARDS AND CALIBRATORS

• IVDD — General medical devices in EUDAMED

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