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SAS Shigella Flexneri Type 3 Antiserum

FDA 510(k)

Class II (US FDA 510(k))

510(k) K961558

by Sa Scientific, Inc.

Identifiers

510(k) Number
K961558 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)

This device is an antiserum used for the detection of Shigella flexneri type 3. It is classified as Antisera, All Types, Shigella Spp. under FDA product code GNB and falls within the microbiology medical specialty.

The device received FDA 510(k) clearance K961558 on May 20, 1996, and is classified as a Class II device. It is supplied as a reagent for laboratory use in microbiological testing, with no indication of sterility, single-use status, or MRI safety provided in the data.

Frequently asked questions

What is the SAS Shigella Flexneri Type 3 Antiserum used for?

This antiserum is used for the detection of Shigella flexneri type 3 in microbiological testing. It is classified as an antiserum for all Shigella species under FDA product code GNB and is intended for laboratory use to identify this specific bacterial serotype in clinical or environmental samples.

How is the SAS Shigella Flexneri Type 3 Antiserum supplied and stored?

The device is supplied as a reagent for laboratory use in microbiological testing. The data does not specify sterility, single-use status, or storage conditions, so users should refer to the manufacturer's labeling for handling, storage, and stability information prior to use.

Is the SAS Shigella Flexneri Type 3 Antiserum a single-use or reusable product?

The provided data does not indicate whether this antiserum is intended for single-use or reuse. As a laboratory reagent, its use pattern depends on the testing protocol and manufacturer's instructions, which are not detailed in the authorization summary.

What regulatory pathway was used for the SAS Shigella Flexneri Type 3 Antiserum?

The device received FDA 510(k) clearance under submission K961558 on May 20, 1996, and was determined to be substantially equivalent to a legally marketed predicate device. It is classified as a Class II device under regulation number 866.3660.

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 FLEXNERI TYPE 3 ANTISERUM - Innolitics, SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM 510(k) K961558 - fda.report, PDF K961558 - Sas Shigella Flexneri Type 3 Antiserum, FDA Product Code GNB - Antisera, All Types, Shigella Spp.

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) K961558 24 fields · synced Sep 21, 2026