BILIRUBIN DPD DIRECT

Organization name

QUIMICA CLINICA APLICADA S.A.

SRN

ES-MF-000001512

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Spain; available across 32 countries total.

Trade name

BILIRUBIN DPD DIRECT

UDI-DI code

18430155009983

Basic UDI-DI

B-18430155009983

Reference / catalog number

990558

Issuing entity

GS1

Risk category

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 Bilirubin DPD Direct is an in vitro diagnostic medical device intended to be used by professional users for the quantitative determination of direct bilirubin in human serum or plasma samples using the DPD colorimetric method, on compatible automated or semi-automated clinical analyzers. Direct bilirubin measurement is used as an aid in the evaluation of conjugated hyperbilirubinemia and in the differentiation of hepatobiliary disorders, including cholestatic and obstructive processes of the biliary tract, as well as hepatocellular alterations affecting biliary excretion.

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.

• W01010203BILIRUBIN