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Organization name
UDI-DI code
Reference / catalog number

Biocard Helicobacter pylori IgG — IVDD — General IVDD

MD Atlas
Labsystems Diagnostics Oy

EUDAMED last updated this device on Jul 10, 2024

Biocard Helicobacter pylori IgG

B-06416842818019

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Labsystems Diagnostics Oy
UDI-DI code: 06416842818019
Reference / catalog number: 3-018-110

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Manufacturer information

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

Critical warnings

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

CW011
If the Instructions for use are not followed in detail, outcome of the test may be false.  Poor observation of the general laboratory precautions in conjunction with the use of the Biocard tests can expose persons to microbial hazards as well as false and misleading results.  Do not use the test after the expiry date.  Do not use the test if the aluminum pouch is damaged. Do not use broken accessories.  All the test components are intended for this test only. Do not reuse tests or accessories.  The sample diluent and positive control contain 0.09 % sodium azide. Avoid contact with the skin. Do not swallow!  A diagnosis should not be made solely according to the Biocard™ Helicobacter pylori IgG –test result. The result should be used in conjunction with additional diagnostic information available for the physician.  Do not use tests from a lot not showing proper performance when tested with controls.  Positive control has been made of pooled, commercial human serums. Although the positive control does not contain infectious agents, it should be handled as a potential biohazard.  General laboratory procedures and precautions shall be followed in the handling and disposal of samples and used materials

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 Helicobacter pylori IgG
UDI-DI code: 06416842818019
Basic UDI-DI: B-06416842818019
Reference / catalog number: 3-018-110
Issuing entity: GS1

Classification

Risk category: IVDD — General
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 an immunochromatographic test for screening of Helicobacter pylori antibodies in whole blood, serum or plasma samples
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Biocard Chlamydia pneumoniae IgMB-06416842034013On the market 3-035-000B-06416842035010On the market 3-028-200B-06416842928015On the market Biocard™ H pylori IgG HomeB-06416842918030On 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.