860001

Organization name

Aesku.Diagnostics GmbH & Co. KG

SRN

DE-MF-000026925

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 17 countries total.

Trade name

not provided

UDI-DI code

04250289511599

Basic UDI-DI

B-04250289511599

Reference / catalog number

860001

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

AESKUCARE® Gluten Related Disorders IgA is a near-patient (point of care) in-vitro-immunoassay intended for the qualitative and quantitative simultaneous measurement of human specific IgA antibodies against human tissue transglutaminase (tTG), neo-epitopes of human tissue transglutaminase (tTG neo), microbial transglutaminase (mTG), neo-epitopes of microbial transglutaminase (mTG neo), deamidated gliadin-specific peptides (DGP), gliadin, peptic-tryptic digests of gliadin (Frazer’s fraction), human epidermal transglutaminase (TG3) and total IgA in heparinized or Na-EDTA venous or capillary whole blood, plasma or serum. The test results, in conjunction with the patient's medical history and other findings, can be used by professionals to make a nutritional recommendation or support a diagnosis of gluten related disorders (GRD). The test should be performed by qualified personnel who are familiar with in vitro diagnostic methods.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0102010101IMMUNOGLOBULIN A