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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

ILE-LBL38 — IVDD — General IVDD by Gold Standard…

MD Atlas
Gold Standard Diagnostics Kassel GmbH

EUDAMED last updated this device on Nov 22, 2023

ILE-LBL38

B-ILE-LBL387M

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: D-ILE-LBL387M
Reference / catalog number: ILE-LBL38

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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: D-ILE-LBL387M
Basic UDI-DI: B-ILE-LBL387M
Reference / catalog number: ILE-LBL38
Issuing entity: EUDAMED

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: IgE Lineblots are Enzyme Immunoassays based on Nitrocellulose Strips which are intended for the detection and the quantitative determination of human IgE antibodies directed towards various specified allergens in serum and plasma. The tests are used as an aid in the diagnostic evaluation of patients with proven or suspected allergic disease. Specific IgE laboratory results can never be the only base of a medical report. The patient history and further tests like skin tests and - if possible - provocation tests have additionally to be taken into account. The tests are designed for in vitro diagnostic use only. They are intended for manual performance by professional users.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01020205IMMUNOGLOBULIN E - SCREEN

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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