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SAS Shigella Dysenteriae Type 8 Antiserum

FDA 510(k)

Class II (US FDA 510(k))

510(k) K961538

by Sa Scientific, Inc.

Identifiers

510(k) Number
K961538 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)

SAS Shigella Dysenteriae Type 8 Antiserum is an antisera device used for microbiology applications. It is classified as Antisera, All Types, Shigella Spp. and is intended for laboratory use in detecting or identifying Shigella dysenteriae type 8 bacteria.

The device is supplied by Sa Scientific, Inc. and is regulated under FDA 510(k) clearance K961538 with a product code of GNB. It is a Class II device with special controls and was cleared on May 20, 1996. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.

Frequently asked questions

What is the SAS Shigella Dysenteriae Type 8 Antiserum used for?

It is intended for laboratory use in detecting or identifying Shigella dysenteriae type 8 bacteria as part of microbiology applications, specifically as an antisera device for serological testing.

How is the SAS Shigella Dysenteriae Type 8 Antiserum supplied and what is its regulatory status?

The device is supplied by Sa Scientific, Inc. and was cleared via FDA 510(k) submission K961538 on May 20, 1996, classified as a Class II device with product code GNB under regulation 866.3660 for Antisera, All Types, Shigella Spp.

Is the SAS Shigella Dysenteriae Type 8 Antiserum sterile or single-use?

The device data does not specify whether the antiserum is sterile, single-use, or reusable; no information regarding sterility or reuse is provided in the available documentation.

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 DYSENTERIAE TYPE 8 ANTISERUM (K961538) — FDA 510(k ..., K961538 FDA 510(k) - SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM, Sas Shigella Dysenteriae Type 8 Antiserum 510 (k) FDA Premarket ..., Sas Shigella Dysenteriae Group A1 (8-10) Antiserum, K961535 FDA 510(k) - SAS SHIGELLA DYSENTERIAE GROUP A1 (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) K961538 24 fields · synced Sep 28, 2026