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RIDASCREEN Norovirus 3RD Generation EIA

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) DEN110001

by R-Biopharm AG

Identifiers

510(k) Number
DEN110001 FDA 510(k)
FDA Product Code
OUC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3395 FDA 510(k)
Regulation Number
866.3395 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
DENG FDA 510(k)

The RIDASCREEN Norovirus 3rd Generation EIA is an enzyme immunoassay for the qualitative detection of norovirus strains from Genogroups I and II. It is classified as a microbiology reagent designed to identify norovirus in human stool samples, aiding in the investigation of acute gastroenteritis outbreaks or sporadic cases.

This device is supplied as a single-use in vitro diagnostic test and is intended for laboratory use only. It requires no special storage conditions beyond refrigeration and is intended for use in settings where microbiological testing is performed. The RIDASCREEN Norovirus 3rd Generation EIA holds FDA 510(k) clearance and IVDR conformity, ensuring compliance with regulatory standards for diagnostic accuracy and safety.

Frequently asked questions

What types of norovirus strains can the RIDASCREEN Norovirus 3rd Generation EIA detect, and how does this help in diagnosing gastroenteritis cases?

The RIDASCREEN Norovirus 3rd Generation EIA is designed to qualitatively detect norovirus strains from Genogroups I and II, which are the most common causes of acute gastroenteritis outbreaks and sporadic cases. By identifying these specific strains in human stool samples, clinicians can confirm norovirus as the causative agent, enabling targeted public health responses, outbreak investigations, or individual patient management.

Is this test intended for point-of-care use, or must it be performed in a laboratory setting?

This test is explicitly intended for laboratory use only and is not designed for point-of-care or bedside testing. It requires specialized equipment, trained personnel, and controlled conditions typical of a microbiology lab, ensuring accurate detection of norovirus in stool samples.

How should the RIDASCREEN Norovirus 3rd Generation EIA be stored, and does it require any special handling?

The test does not require special storage conditions beyond standard refrigeration (typically 2–8°C). It is supplied as a single-use device, so once opened or exposed to room temperature, it should be used immediately to maintain test integrity. Avoid freezing and protect from light to preserve performance.

Is this test reusable, or is it meant for single-use only?

The RIDASCREEN Norovirus 3rd Generation EIA is strictly single-use per the manufacturer’s specifications. Each test kit is designed for one use only, ensuring consistency in results and compliance with laboratory protocols for infectious disease testing.

What regulatory pathways does this device follow, and how does that affect its use in clinical settings?

The device holds FDA 510(k) clearance (K-number: DEN110001) and IVDR conformity, meaning it meets U.S. and EU regulatory standards for diagnostic accuracy and safety. Clinicians can rely on its compliance with these frameworks, which include rigorous validation for detecting norovirus in stool samples, ensuring reliable results for outbreak investigations or individual diagnostics.

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: RIDASCREEN® Norovirus - 3rd Generation - Clinical Diagnostics, RIDASCREEN® Norovirus 3rd Generation (FDA cleared), RIDASCREEN® Norovirus 3rd Generation - R-Biopharm AG

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
R-Biopharm AG

Sources (2)

  • FDA 510(k) DEN110001 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026