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Organization name
UDI-DI code
Reference / catalog number

37113016 — IVDD — General IVDD by Gold Standard…

MD Atlas
Gold Standard Diagnostics Kassel GmbH

EUDAMED last updated this device on May 26, 2025

37113016

B-04260153755066

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: 04260153755066
Reference / catalog number: 37113016

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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.

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: not provided
UDI-DI code: 04260153755066
Basic UDI-DI: B-04260153755066
Reference / catalog number: 37113016
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: The Gold Standard Diagnostics Kassel Spez. IgE test system is a paper disc-based enzyme immunoassay for the quantitative detection of allergen specific IgE antibodies against various allergens in human serum and plasma. It is composed of Gold Standard Diagnostics Kassel Spez. IgE kits (Spez. IgE S and XL) and Gold Standard Diagnostics Kassel Spez. IgE Discs (available for various allergens) which can only be used in combination and need to be ordered separately. The Spez. IgE test system is intended for in vitro diagnostic use as an aid in the diagnostic evaluation of patients with proven or suspected IgE-mediated allergic disorders. It is designed for manual processing by professional users experienced in the use of in vitro diagnostic methods (e.g., laboratory qualified personnel). Specific IgE results should always be used in combination with other clinical findings such as the patient history and further tests like skin prick tests and - if possible - provocation tests. Positive and negative specific IgE results cannot predict or rule out a future anaphylactic reaction to a specific allergen.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01020202IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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