INNODX f-PSA CMIA

Trade name

INNODX f-PSA CMIA

UDI-DI code

06973600799282

Basic UDI-DI

697360079023JT

Reference / catalog number

KR-f-PSA-02100

Issuing entity

GS1

Risk category

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

This kit is used for quantitative detection of free prostate-specific antigen (f-PSA) in human serum or plasma, and it is intended to be used for the auxiliary diagnosis of prostate cancer and dynamic monitoring of malignant tumor patients to assist in judging the disease process or treatment effect. This kit is used in combination with the fully automated chemiluminescence immunoassay system.

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.

• W0102030114FREE PROSTATIC SPECIFIC ANTIGEN

2 warnings recorded — scroll inside the panel to see all entries.

• CW083

  EUDAMED did not publish a description for this code.
• CW106

  EUDAMED did not publish a description for this code.

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