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Xpect Giardia Lateral Flow Assay, Model 2450020

FDA 510(k)

Class II (US FDA 510(k))

510(k) K031942

by Remel, Inc.

Identifiers

510(k) Number
K031942 FDA 510(k)
FDA Product Code
MHI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3220 FDA 510(k)
Regulation Number
866.3220 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Xpect Giardia Lateral Flow Assay, Model 2450020, is a chromatographic immunoassay for detecting Giardia antigen in fecal specimens. It is used for the direct qualitative detection of Giardia-specific antigen. The assay involves adding a fecal specimen to a dilution tube with buffered solution and conjugate containing colored micro-particles linked to murine monoclonal anti-Giardia antibody.

The Xpect Giardia Lateral Flow Assay, Model 2450020, is supplied as a kit and is used in microbiology laboratories. It is a rapid, lateral flow immunoassay with excellent clinical sensitivity and specificity. The device has been authorized with an FDA 510K clearance, and its regulation number is 866.3220. The assay is designed for use with fresh, frozen, or preserved human fecal specimens.

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: Xpect™ Giardia Test 20 Tests/Kit - Thermo Scientific™, Xpect Giardia Lateral Flow Assay, Model 2450020, Thermo Scientific™ Xpect™ Giardia Test - Fisher Sci

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Remel, Inc.

Sources (1)

  • FDA 510(k) K031942 24 fields · synced Sep 21, 2026