← Back to catalogue

Sas Salmonella H Poly A Antiserum

FDA 510(k)

Class II (US FDA 510(k))

510(k) K955200

by Sa Scientific, Inc.

Identifiers

510(k) Number
K955200 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)

Sas Salmonella H Poly A Antiserum is an antigenic reagent classified under the FDA device class as an antigens, febrile, slide and tube test for all groups of Salmonella spp. It is used in microbiology laboratories to identify Salmonella H antigens and to provide epidemiological information for salmonellosis diagnosis.

The product is cleared through a traditional FDA 510(k) submission (K955200) and is assigned product code GNC as a Class II device. It is supplied as a sterile antiserum reagent for laboratory use, intended for single‑use application in slide or tube testing procedures.

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 H POLY A ANTISERUM by SA SCIENTIFIC, INC. | FDA 510(k ..., SAS SALMONELLA H POLY A ANTISERUM (K955200) - FDA 510 (k), SAS SALMONELLA H POLY A ANTISERUM - Innolitics, SAS SALMONELLA H POLY A-Z ANTISERUM - Innolitics, BD Difco™ Salmonella H Antiserum Poly A 3Ml - 225391 | BD

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sa Scientific, Inc.

Sources (1)

  • FDA 510(k) K955200 24 fields · synced Oct 1, 2026