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SAS Influenza B Test

FDA 510(k)

Class II (US FDA 510(k))

510(k) K041439

by Sa Scientific, Inc.

Identifiers

510(k) Number
K041439 FDA 510(k)
FDA Product Code
PSZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3328 FDA 510(k)
Regulation Number
866.3328 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SAS Influenza B Test is an in‑vitro diagnostic device classified under Devices Detecting Influenza A, B, and C Virus Antigens. It provides a qualitative detection of Influenza B antigen in nasal aspirates or washes, enabling identification of the common circulating strains of the virus.

The test is supplied as a single‑use kit for use in virology or microbiology laboratories. It received traditional FDA 510(k) clearance (K041439) on 22 July 2004 and is assigned to product code PSZ, class II. The device is intended for clinical laboratory use under standard aseptic storage conditions; no specific sterility or MRI safety claims are provided in the data.

Frequently asked questions

What is the SAS Influenza B Test used for?

The SAS Influenza B Test is an in-vitro diagnostic device used for qualitative detection of Influenza B antigen in nasal aspirates or washes. It helps identify common circulating strains of the virus in clinical laboratory settings.

How is the SAS Influenza B Test supplied?

The test is supplied as a single-use kit specifically designed for use in virology or microbiology laboratories. Each kit contains all necessary components for performing the test according to the manufacturer's instructions.

What are the storage requirements for the SAS Influenza B Test?

The device should be stored under standard aseptic conditions as specified by the manufacturer. No specific sterility claims are provided, but proper storage conditions are essential to maintain test integrity and accuracy.

Is the SAS Influenza B Test cleared by regulatory authorities?

Yes, the SAS Influenza B Test received traditional FDA 510(k) clearance with number K041439 on July 22, 2004. It is classified as a class II device under product code PSZ for detecting Influenza A, B, and C virus antigens.

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: SA Scientific SAS Influenza B Test (3955) - PULSEAID, FluAlert A&B Product Sheet - SA Scientific - MedicalExpo, SAScientific and You - SA Scientific Ltd.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sa Scientific, Inc.

Sources (1)

  • FDA 510(k) K041439 24 fields · synced Sep 24, 2026