016

Trade name

not provided

UDI-DI code

06976043630167

Basic UDI-DI

B-06976043630167

Reference / catalog number

016

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 product is used for the quantitative determination of anti-dsDNA antibody in human serum, plasma and whole blood in vitro. In clinical practice,it is mainly used for the auxiliary diagnosis of systemic lupus erythematosus and to monitor the changes in the clinical course (especially lupus nephritis).

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.

• W01020201IMMUNOGLOBULIN E - TOTAL

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

• CW011

  1.For in vitro diagnostic use only. Follow the instructions strictly. 2.Diagnosis should be made by integrating results with other clinical findings.

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