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SAS Shigella Boydii Type 7 Antiserum

FDA 510(k)

Class II (US FDA 510(k))

510(k) K953328

by Sa Scientific, Inc.

Identifiers

510(k) Number
K953328 FDA 510(k)
FDA Product Code
GNB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3660 FDA 510(k)
Regulation Number
866.3660 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SAS Shigella Boydii Type 7 Antiserum is a laboratory reagent used in qualitative slide agglutination tests for the serological identification of Shigella species. This specific antiserum is designed to identify Shigella boydii Type 7 isolates, which belong to subgroup C of Shigella classification. The product is manufactured by Sa Scientific, Inc. and is classified as Antisera, All Types, Shigella Spp.

This device is supplied as a 3ml volume and is intended for laboratory use in microbiology settings. The SAS Shigella Boydii Type 7 Antiserum is a Class II device cleared by the FDA under 510(k) K953328 on August 2, 1995, with product code GNB. It is regulated under special controls and is not specified as single-use or reusable in the provided data.

Frequently asked questions

What is the SAS Shigella Boydii Type 7 Antiserum used for?

The SAS Shigella Boydii Type 7 Antiserum is a laboratory reagent specifically designed for qualitative slide agglutination tests to serologically identify Shigella boydii Type 7 isolates, which belong to subgroup C of Shigella classification in microbiology settings.

How is the SAS Shigella Boydii Type 7 Antiserum supplied?

This laboratory reagent is supplied as a 3ml volume and is intended for laboratory use in microbiology settings. It is manufactured by Sa Scientific, Inc. and is classified as Antisera, All Types, Shigella Spp.

What is the regulatory status of the SAS Shigella Boydii Type 7 Antiserum?

The SAS Shigella Boydii Type 7 Antiserum is a Class II device cleared by the FDA under 510(k) K953328 on August 2, 1995, with product code GNB. It is regulated under special controls, and the provided data does not specify whether it is single-use or reusable.

What Shigella species can be identified using this antiserum?

This specific antiserum is designed to identify Shigella boydii Type 7 isolates, which belong to subgroup C of Shigella classification. It is not intended for identifying other Shigella species or subtypes.

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 SHIGELLA BOYDII TYPE 7 ANTISERUM - Innolitics, K953328 FDA 510(k) - SAS SHIGELLA BOYDII TYPE 7 ANTISERUM, Shigella Antiserum Poly, Group C, S. boydii Types 1-7, 3ml, K961546 FDA 510(k) - SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ...

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) K953328 24 fields · synced Sep 28, 2026