Zeus Scientific Inc., Tpo Igg Elisa Test System.
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K991610 FDA 510(k)
- FDA Product Code
- DDC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5870 FDA 510(k)
- Regulation Number
- 866.5870 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative and semi-quantitative detection of IgG-class antibodies to thyroid peroxidase (TPO) in human serum. It is intended to assist in the identification of TPO antibodies, which are associated with autoimmune thyroid disorders.
The test system is supplied as a kit and is intended for single-use in laboratory settings. It is not specified as sterile, reusable, or MRI-safe. The device is regulated under FDA 510(k) clearance (K991610) and is classified under medical specialty Immunology.
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: TPO IgG Test System - zeusscientific.com, ZEUS ELISA™ Test Systems - ZEUS Scientific, Zeus Scientific Inc., Tpo Igg Elisa Test System., ZEUS SCIENTIFIC, INC. SM2Z5051G ELISA TPO IgG Smart Kit Test System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K991610 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zeus Scientific, Inc.
Sources (1)
- FDA 510(k) K991610 24 fields · synced Sep 25, 2026