Quanta Lite Celiac Dgp Screen
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K062708 FDA 510(k)
- FDA Product Code
- MST FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5750 FDA 510(k)
- Regulation Number
- 866.5750 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Quanta Lite Celiac Dgp Screen is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgA and IgG antibodies to synthetic deaminated gliadin-derived peptides in human serum. It is used for the detection of antibodies related to celiac disease and dermatitis herpetiformis. The device is classified as an Immunology device.
The Quanta Lite Celiac Dgp Screen is supplied as a reagent for use in laboratory settings. It is regulated under the product code MST and has been cleared by the FDA under the traditional 510(k) clearance process, with the clearance number K062708. The device is intended for use in the diagnosis of celiac disease and related conditions.
Frequently asked questions
What is the Quanta Lite Celiac Dgp Screen used for?
The Quanta Lite Celiac Dgp Screen is used for the semi-quantitative detection of IgA and IgG antibodies to synthetic deaminated gliadin-derived peptides in human serum, aiding in the diagnosis of celiac disease and related conditions.
How is the Quanta Lite Celiac Dgp Screen supplied?
The Quanta Lite Celiac Dgp Screen is supplied as a reagent for use in laboratory settings.
What is the regulatory status of the Quanta Lite Celiac Dgp Screen?
The Quanta Lite Celiac Dgp Screen has been cleared by the FDA under the traditional 510(k) clearance process, with the clearance number K062708.
What type of device is the Quanta Lite Celiac Dgp Screen?
The Quanta Lite Celiac Dgp Screen is classified as an Immunology device, specifically an enzyme-linked immunosorbent assay (ELISA).
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. Sources consulted: QUANTA LITE CELIAC DGP SCREEN (K062708) - FDA 510 (k), QUANTA LITE CELIAC DGP SCREEN (K062708) — FDA 510 (k) | Innolitics, QUANTA Lite (R) Celiac DGP Screen Reagents - Werfen
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062708 | Class II | Active |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (1)
- FDA 510(k) K062708 24 fields · synced Sep 24, 2026