3-028-200

Organization name

Labsystems Diagnostics Oy

SRN

FI-MF-000018281

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 1 country total.

Placed on the market in Finland; per-country availability dates not published.

Trade name

not provided

UDI-DI code

06416842928015

Basic UDI-DI

B-06416842928015

Reference / catalog number

3-028-200

Issuing entity

GS1

Risk category

IVDD — Self-testing

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

Biocard™ Celiac Test is a rapid, simple and reliable home test for the detection of celiac disease associated IgA autoantibodies from fingertip blood sample.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102100602TISSUE TRANSGLUTAMINASE/ GLIADIN ANTIBODIES COMBITEST

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification