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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

IgG4 Screen OMNI1 — IVDD — General IVDD by Gold Standard…

MD Atlas
Gold Standard Diagnostics Kassel GmbH

EUDAMED last updated this device on Aug 26, 2025

IgG4 Screen OMNI1

B-04260153751228

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Gold Standard Diagnostics Kassel GmbH
UDI-DI code: 04260153751228
Reference / catalog number: ILE-SCG902

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Manufacturer information

Organization name: Gold Standard Diagnostics Kassel GmbH
SRN: DE-MF-000021646
Manufacturer status: Active

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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.

CW041
1 M NaOH

Market distribution

Primary placement in Germany; available across 1 country total.

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

Device identification

Trade name: IgG4 Screen OMNI1
UDI-DI code: 04260153751228
Basic UDI-DI: B-04260153751228
Reference / catalog number: ILE-SCG902
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: Food Intolerance IgG4 Screen ELISAs are Enzyme Immunoassays based on Microtiter Plates which are intended for the detection and the quantitative determination of human IgG antibodies directed towards various specified antigens in serum and plasma. The tests are designed for in vitro diagnostic use only. They are intended for manual performance by trained professional users.
Additional information URL: https://htps//kassel.goldstandarddiagnostics.com/home/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01020208ALLERGENE SPECIFIC IGG

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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