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CMV-IGM IFA Test System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K900743

by Zeus Scientific, Inc.

Identifiers

510(k) Number
K900743 FDA 510(k)
FDA Product Code
LKQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3175 FDA 510(k)
Regulation Number
866.3175 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CMV-IGM IFA Test System is an indirect fluorescent antibody assay for the qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum. This test system is used to evaluate serologic evidence of primary or reactivated infection with CMV and is intended for in vitro diagnostic use.

The test system is supplied as a kit for laboratory use and is not described as single-use or reusable in the provided data. It is not specified as MRI safe. The device received FDA 510(k) clearance on April 26, 1990, with product code LKQ and is classified as Class II by the FDA.

Frequently asked questions

What is the CMV-IGM IFA Test System used for?

The CMV-IGM IFA Test System is an indirect fluorescent antibody assay used for the qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum. It helps evaluate serologic evidence of primary or reactivated infection with CMV and is intended for in vitro diagnostic use in laboratories.

How is the CMV-IGM IFA Test System supplied?

The test system is supplied as a kit for laboratory use. The provided data does not specify whether it is single-use or reusable, indicating it should be used according to the manufacturer's instructions and laboratory protocols.

What is the regulatory status of the CMV-IGM IFA Test System?

The CMV-IGM IFA Test System received FDA 510(k) clearance on April 26, 1990, with product code LKQ and is classified as Class II by the FDA. This means it has been determined to be substantially equivalent to other legally marketed devices.

What does the CMV-IGM IFA Test System detect?

The test system detects IgM antibodies to cytomegalovirus (CMV) in human serum. The presence of IgM antibodies can indicate a recent or primary CMV infection, as IgM is typically the first antibody produced in response to an infection.

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: CMV IgM Test System - ZEUS Scientific, ZEUS SCIENTIFIC, INC. FA9001M IFA CMV IgM Test System - RevMed, CMV-IGM IFA TEST SYSTEM (K900743) — FDA 510 (k) | Innolitics, AccessGUDID - DEVICE: IFA CMV IgM Test System (00845533001540)

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) K900743 24 fields · synced Sep 27, 2026