Identifiers
- 510(k) Number
- K010625 FDA 510(k)
- FDA Product Code
- MVM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5660 FDA 510(k)
- Regulation Number
- 866.5660 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EUROSPITAL EU-TTG IGA UMANA is an in vitro diagnostic device used for the detection of autoantibodies, specifically Endomysial (Tissue Transglutaminase), in human samples. This device is classified under the Immunology medical specialty and is designed to assist in the diagnosis of conditions related to these autoantibodies.
The device is supplied as a Class II medical device with FDA 510(k) clearance (K010625) and is regulated under product code MVM. It is manufactured by Scimedx Corp. and is intended for laboratory use. The device does not appear to be single-use or reusable, and no specific information regarding sterility, MRI safety, or storage conditions is provided in the data.
Frequently asked questions
What is the EUROSPITAL EU-TTG IGA UMANA device used for?
The EUROSPITAL EU-TTG IGA UMANA is an in vitro diagnostic device designed to detect autoantibodies, specifically Endomysial (Tissue Transglutaminase), in human samples. It assists in the diagnosis of conditions related to these autoantibodies and is classified under the Immunology medical specialty.
How is the EUROSPITAL EU-TTG IGA UMANA supplied and what is its intended use?
The device is supplied as a Class II medical device intended for laboratory use. It is manufactured by Scimedx Corp. and does not appear to be single-use or reusable. No specific information regarding sterility, MRI safety, or storage conditions is provided in the available data.
What is the regulatory status of the EUROSPITAL EU-TTG IGA UMANA device?
The device has FDA 510(k) clearance with number K010625 and is regulated under product code MVM. It was classified as substantially equivalent and received clearance through the traditional review process by the Immunology advisory committee.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K010625 | Class II | Active |
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Manufacturer
- Manufacturer
- Scimedx Corp.
Sources (1)
- FDA 510(k) K010625 24 fields · synced Sep 23, 2026