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Unicap Thyroglobulin Igg Assay, Unicap Thyroid Peroxidase Igg Assay

FDA 510(k)

Class II (US FDA 510(k))

510(k) K981559

by Pharmacia & Upjohn Co.

Identifiers

510(k) Number
K981559 FDA 510(k)
FDA Product Code
JZO 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 Unicap Thyroglobulin Igg Assay and Unicap Thyroid Peroxidase Igg Assay are in vitro diagnostic tests for the quantitative measurement of IgG antibodies specific for Thyroglobulin and Thyroid Peroxidase in human serum and plasma. These assays are part of the UniCAP system, an integrated and automated immunodiagnostic platform for fluoroenzymeimmunoassays.

The Unicap Thyroglobulin Igg Assay and Unicap Thyroid Peroxidase Igg Assay are supplied for use with the UniCAP 100 analyzer, which automates sample and reagent handling and processing. The devices have been assigned the product code JZO and regulation number 866.5870, and have been cleared by the FDA under the 510(k) clearance type, with the k number K981559.

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: Unicap Thyroglobulin Igg Assay, Unicap Thyroid Peroxidase Igg Assay ..., Unicap Thyroglobulin Igg Assay, Unicap Thyroid Peroxidase Igg Assay 510 ..., UNICAP THYROID PEROXIDASE IGG (K981930) — FDA 510(k) | Innolitics, K981559 FDA 510 (k) - UNICAP THYROGLOBULIN IGG ASSAY

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pharmacia & Upjohn Co.

Sources (1)

  • FDA 510(k) K981559 24 fields · synced Sep 21, 2026