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SAS Salmonella 0 Factor Factor 5 Antiserum

FDA 510(k)

Class II (US FDA 510(k))

510(k) K960163

by Sa Scientific, Inc.

Identifiers

510(k) Number
K960163 FDA 510(k)
FDA Product Code
GRM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3550 FDA 510(k)
Regulation Number
866.3550 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an antiserum for Salmonella spp., specifically targeting the O factor 5 antigen. It is used in microbiology laboratory settings for the identification and serotyping of Salmonella bacteria.

The product is supplied as a reagent for in vitro diagnostic use. It is intended for use by trained laboratory personnel and is regulated under FDA 510(k) clearance as a class II device with product code GRM.

Frequently asked questions

What is the SAS Salmonella O Factor 5 Antiserum used for?

This antiserum is used in microbiology laboratories to identify and serotype Salmonella bacteria by specifically targeting the O factor 5 antigen. It supports the differentiation of Salmonella species based on their surface antigens, which is essential for accurate bacterial classification and epidemiological tracking.

How is the SAS Salmonella O Factor 5 Antiserum supplied and intended for use?

The product is supplied as a reagent for in vitro diagnostic use and is intended for use by trained laboratory personnel. It is not a standalone test but a component used within established laboratory procedures for bacterial serotyping, requiring proper handling and expertise to ensure reliable results.

Is the SAS Salmonella O Factor 5 Antiserum a single-use or reusable reagent?

The device data does not specify whether the antiserum is single-use or reusable. As an in vitro diagnostic reagent, its use depends on laboratory protocols and stability after opening; users should consult the product labeling or manufacturer’s instructions for specific guidance on storage, stability, and reuse limitations.

What regulatory pathway was used for the SAS Salmonella O Factor 5 Antiserum?

The device was cleared through the FDA 510(k) process, as indicated by the AUTHORIZATIONS field listing FDA_510K and the k-number K960163. It is regulated as a Class II medical device under product code GRM, with a determination of substantial equivalence to a legally marketed predicate device.

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.

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) K960163 24 fields · synced Sep 23, 2026