FCAPCR-25

Trade name

not provided

UDI-DI code

06970514081045

Basic UDI-DI

B-06970514081045

Reference / catalog number

FCAPCR-25

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

This kit is used for in vitro qualitative detection of Candida DNA infected in alveolar lavage fluid or sputum from individuals who are suspected of Candida infection by their healthcare provider，and can be used for auxiliary diagnosis and monitoring the efficacy of Candida patients infected with drug treatment. The test results are for clinical reference only, and should not be used as the sole basis for diagnosis of Candida infection. It is recommended to conduct a comprehensive analysis of the patient's condition combined with clinical manifestations and other laboratory tests.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105060402CANDIDA ALBICANS - NA REAGENTS

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

• CW010

  EUDAMED did not publish a description for this code.

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