Varelisa Gliadin Igg Antibodies
by Sweden Diagnostics (Germany) GmbH
510(k) K041357
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041357 | Date2 Aug 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MST
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5750
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
Varelisa Gliadin IgG Antibodies is an enzyme immunoassay kit designed for the semiquantitative and qualitative determination of gliadin antibodies. This diagnostic device is classified as an antibody test for gliadin, which is used in the field of immunology.
This device is supplied by Sweden Diagnostics (Germany) GmbH and has received FDA 510(k) clearance. It is categorized under regulation number 866.5750 and product code MST. The device is intended for professional use within clinical laboratory settings.
Other devices from Sweden Diagnostics (Germany) GmbH
Questions
AI-generated answers, 6 Oct 2026
What is the intended use of the Varelisa Gliadin IgG Antibodies kit?
The Varelisa Gliadin IgG Antibodies kit is an enzyme immunoassay designed for the semiquantitative and qualitative determination of gliadin antibodies in clinical laboratory settings.
Who is authorized to use this diagnostic device?
This device is intended for professional use only and is designed to be utilized within clinical laboratory environments by trained personnel.
What is the regulatory status of this antibody test?
The device has received FDA 510(k) clearance under regulation number 866.5750 and product code MST, confirming its regulatory status for use in immunology testing.