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Sas Salmonella H Z23 Antiserum

FDA 510(k)

Class II (US FDA 510(k))

510(k) K960603

by Sa Scientific, Inc.

Identifiers

510(k) Number
K960603 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)

The Sas Salmonella H Z23 Antiserum is an in vitro diagnostic reagent classified as an antisera for Salmonella species. It is used to identify specific Salmonella serotypes through agglutination reactions in a laboratory setting.

This device is supplied by Sa Scientific, Inc. and has received FDA 510(k) clearance under the regulation number 866.3550. It is categorized under product code GRM and is intended for use in microbiology applications.

Frequently asked questions

What is the primary use of the SAS Salmonella H Z23 Antiserum?

This reagent is intended for use in laboratory microbiology applications to identify specific Salmonella serotypes. It functions by facilitating agglutination reactions, which allow clinicians and lab technicians to classify the bacterial species present in a sample.

What is the regulatory status of this antiserum?

The SAS Salmonella H Z23 Antiserum has received FDA 510(k) clearance under regulation number 866.3550. It is classified as a class 2 medical device under product code GRM, which pertains to antisera used for the identification of Salmonella species.

Who is the manufacturer of this diagnostic reagent?

This device is manufactured by Sa Scientific, Inc., based in San Antonio, Texas. The company is the official applicant for the FDA 510(k) clearance associated with this specific antiserum product.

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 Z23 ANTISERUM (K960603) — FDA 510 (k) | Innolitics, SAS SALMONELLA H Z4, Z23 ANTISERUM (K955187) - FDA 510 (k), SAS SALMONELLA H Z23 ANTISERUM (K960603) - FDA 510 (k), SAS SALMONELLA H Z4, Z23 ANTISERUM - fda.innolitics.com, SAS SALMONELLA H Z23 ANTISERUM (K960603) — FDA 510 (k) | Innolitics

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) K960603 24 fields · synced Sep 22, 2026