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Zorba IgG Removal Reagent

FDA 510(k)

Class II (US FDA 510(k))

510(k) K924197

by Zeus Scientific, Inc.

Identifiers

510(k) Number
K924197 FDA 510(k)
FDA Product Code
DEW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5510 FDA 510(k)
Regulation Number
866.5510 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Zorba IgG Removal Reagent is an in vitro diagnostic reagent designed for the functional removal of potentially interfering immunoglobulin G (IgG) antibodies from human serum. It is classified under antigen, antiserum, and control devices, specifically for immunology applications. The reagent facilitates accurate detection of IgM antibodies by eliminating IgG interference, ensuring more reliable diagnostic results.

This reagent is supplied as a single-use diagnostic tool for laboratory settings and is regulated under FDA 510(k) clearance (K924197). It adheres to regulatory requirements for in vitro diagnostic devices, with no indication of MRI compatibility or reusable components. Storage and handling follow standard in vitro diagnostic protocols, and its use is governed by the specified regulatory framework (866.5510) for immunology-related products.

Frequently asked questions

What is the purpose of the Zorba IgG Removal Reagent?

The Zorba IgG Removal Reagent is an in vitro diagnostic tool designed to remove potentially interfering immunoglobulin G (IgG) antibodies from human serum, allowing for more accurate detection of IgM antibodies in laboratory diagnostics.

How is the Zorba IgG Removal Reagent supplied?

The reagent is supplied as a single-use diagnostic tool specifically designed for laboratory settings, following standard in vitro diagnostic protocols for handling and storage.

What regulatory status does the Zorba IgG Removal Reagent have?

The Zorba IgG Removal Reagent is regulated under FDA 510(k) clearance (K924197) and is classified under antigen, antiserum, and control devices for immunology applications.

Can the Zorba IgG Removal Reagent be reused?

No, the Zorba IgG Removal Reagent is supplied as a single-use diagnostic tool and is not designed for reuse in laboratory settings.

What is the primary application of the Zorba IgG Removal Reagent?

The reagent is primarily used in immunology applications to facilitate accurate detection of IgM antibodies by eliminating IgG interference, ensuring more reliable diagnostic results in laboratory settings.

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: Zorba IgG Removal Reagent - ZEUS Scientific, PDF Zorba® IgG Removal Reagent IVD - ZEUS Scientific, ZEUS SCIENTIFIC, INC. FA003G ZORBA IgG Removal Reagent, ZORBA(TM) IGG REMOVAL REAGENT (K924197) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zeus Scientific, Inc.

Sources (1)

  • FDA 510(k) K924197 24 fields · synced Sep 19, 2026