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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™ Helicobacter pylori Urease — IVDD — General IVDD

MD Atlas
Labsystems Diagnostics Oy

EUDAMED last updated this device on Aug 8, 2024

Biocard™ Helicobacter pylori Urease

B-06416842618015

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: 06416842618015
Reference / catalog number: 3-018-945

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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™ H pylori IgG HomeB-06416842918030On the market

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 Urease
UDI-DI code: 06416842618015
Basic UDI-DI: B-06416842618015
Reference / catalog number: 3-018-945
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: In vitro diagnostic test for the rapid detection of urease activity in gastric or duodenal biopsy specimens
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105010499H. PYLORI REAGENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Manufacturing date
Serial number
Software identification

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.