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SAS Salmonella VI Antigen

FDA 510(k)

Class II (US FDA 510(k))

510(k) K953844

by Sa Scientific, Inc.

Identifiers

510(k) Number
K953844 FDA 510(k)
FDA Product Code
GNC 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)

Salmonella spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify Salmonella spp. from cultured isolates derived from clinical specimens. The SAS Salmonella VI Antigen is an antigen component of such reagents, intended for use in laboratory testing to detect Salmonella VI antigen.

This device is supplied as a reagent for in vitro diagnostic use in microbiology laboratories. It is not sterile, not intended for single-use or reusable classification in the traditional sense, and has no stated MRI safety information. Storage conditions and specific sizes are not detailed in the provided data. The device received FDA 510(k) clearance under K953844, with a traditional clearance type and substantial equivalence determination, and is classified under regulation number 866.3550.

Frequently asked questions

What is the SAS Salmonella VI Antigen used for?

The SAS Salmonella VI Antigen is used as a reagent component in serological tests to identify Salmonella VI antigen from cultured isolates derived from clinical specimens in microbiology laboratories.

Is the SAS Salmonella VI Antigen sterile or intended for single use?

The SAS Salmonella VI Antigen is supplied as a non-sterile reagent for in vitro diagnostic use and is not classified as single-use or reusable in the traditional sense, as it is a laboratory reagent rather than a device intended for patient contact or repeated processing.

How is the SAS Salmonella VI Antigen supplied and stored?

The device is supplied as a reagent for in vitro diagnostic use in microbiology laboratories; however, specific storage conditions, sizes, or packaging details are not provided in the available data.

What regulatory pathway was used for the SAS Salmonella VI Antigen?

The SAS Salmonella VI Antigen received FDA 510(k) clearance under K953844 through a traditional submission pathway, 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. Sources consulted: SAS SALMONELLA VI ANTIGEN (K953844) - FDA 510 (k), PDF K953844 SAS SALMONELLA VI ANTIGEN - 510kdatabase.net, Products - SA Scientific Ltd., SAS SALMONELLA H FACTOR 6 ANTISERUM by SA SCIENTIFIC, INC. | FDA 510(k ..., Sa-Scientific FDA Filings - FDA.report

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) K953844 24 fields · synced Sep 21, 2026