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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Biocard™ H pylori IgG Home — IVDD — Self-testing IVDD

MD Atlas
Labsystems Diagnostics Oy

EUDAMED last updated this device on Jul 10, 2024

Biocard™ H pylori IgG Home

B-06416842918030

On the marketIVDD — Self-testing

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Labsystems Diagnostics Oy
UDI-DI code: 06416842918030
Reference / catalog number: 3-018-200

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Manufacturer information

Organization name: Labsystems Diagnostics Oy
SRN: FI-MF-000018281
Manufacturer status: Active

Related devices

Biocard Chlamydia pneumoniae IgMB-06416842034013On the market Biocard Helicobacter pylori IgGB-06416842818019On the market 3-035-000B-06416842035010On the market 3-028-200B-06416842928015On the market Biocard™ Helicobacter pylori UreaseB-06416842618015On the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

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

CW011
The accuracy of Biocard™ result depends on the proper testing. - If the instructions for use are not followed in detail, outcome of the test may be false. - A final diagnosis should only be made by a medical doctor, in conjunction with the clinical symptoms and further laboratory data. - Do not use the test after the expiry date. - Do not use the test if the aluminum pouch or accessories are damaged - All the test components are intended for this test only. Do not reuse test device or accessories - Dispose all components in the original test package, as normal household waste - The sample buffer contains 0,09 % sodium azide. Avoid contact with the skin. Do not swallow! - Please keep the test out of the reach of children.

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: Biocard™ H pylori IgG Home
UDI-DI code: 06416842918030
Basic UDI-DI: B-06416842918030
Reference / catalog number: 3-018-200
Issuing entity: GS1

Classification

Risk category: IVDD — Self-testing
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Biocard™ Helicobacter pylori IgG is a home test for the detection of Helicobacter pylori antibodies from a fingertip blood sample.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105010402H. PYLORI ANTIBODY ASSAYS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification