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Basic Information
- Primary DI
- 05060169694163
- Basic UDI-DI Code
- 5060169694163XL
- Reference
- IS-AI1303
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Immunodiagnostic Systems Limited
Additional Description
The IDS t-TG IgA assay is an in vitro diagnostic device intended for the quantitative determination of specific IgA antibodies directed against tissue transglutaminase (t-TG) in human serum or plasma (EDTA, heparin) on the IDS system. For samples that do not contain anti-t-TG IgA, the assay also provides an indication of the concentration of the total IgA present in the sample. Results are to be used in conjunction with other clinical and laboratory data as an aid in the evaluation of systemic of gluten enteropathy (celiac disease - CD) and dermatitis herpetiformis (Durhing’s disease).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102100601 | TISSUE TRANSGLUTAMINASE ANTIBODIES |
Available In Countries
Similar Devices
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