Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

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

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

IgG4 Screen OMNI2 — IVDD — General IVDD by Gold Standard…

MD Atlas
Gold Standard Diagnostics Kassel GmbH

EUDAMED last updated this device on Aug 26, 2025

IgG4 Screen OMNI2

B-04260153751235

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: 04260153751235
Reference / catalog number: ILE-SCG904

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

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 OMNI2
UDI-DI code: 04260153751235
Basic UDI-DI: B-04260153751235
Reference / catalog number: ILE-SCG904
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

IgG Vorscreen OMNIB-04260153751174On the market IgG / IgG4 Vorscreen OMNIB-04260153751167On the market IgG Screen Nutritional 24 ELISAB-04260153751075On the market IgG Screen Nutritional 24 ET ELISAB-04260153751099On the market IgG Screen Nutritional 88 ELISAB-04260153751082On 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.