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SAS Shigella Sonnei Form II Antiserum

FDA 510(k)

Class II (US FDA 510(k))

510(k) K961537

by Sa Scientific, Inc.

Identifiers

510(k) Number
K961537 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 product is a Shigella Sonnei Form II Antiserum, classified under the nomenclature for antisera targeting Shigella species. It is a diagnostic reagent designed for the identification and differentiation of Shigella sonnei bacteria in microbiological testing, aiding in the confirmation of bacterial infections through serological methods. The device falls under the regulatory category for antisera and is intended for laboratory use in microbiology settings.

The SAS Shigella Sonnei Form II Antiserum is supplied as a sterile, ready-to-use reagent for in vitro diagnostic use. It is intended for single-use and requires no special storage conditions beyond refrigeration, as specified in its regulatory submission. The product holds an FDA 510(k) clearance (K961537) under the Traditional review pathway, with a classification as a Class II device. No additional sterility or MRI safety considerations apply, as it is not intended for implantation or imaging use.

Frequently asked questions

What is the SAS Shigella Sonnei Form II Antiserum used for?

This antiserum is a diagnostic reagent designed specifically for identifying and differentiating *Shigella sonnei* bacteria in microbiological testing. It helps confirm bacterial infections through serological methods, ensuring accurate identification in laboratory settings.

How is the SAS Shigella Sonnei Form II Antiserum supplied and prepared for use?

The product is supplied as a sterile, ready-to-use reagent, requiring no additional preparation before use. It is intended exclusively for in vitro diagnostic applications in microbiology labs.

Is the SAS Shigella Sonnei Form II Antiserum single-use or reusable?

This antiserum is designed for single-use only. After one application, it should not be reused to maintain accuracy and sterility, as per its regulatory submission requirements.

What storage conditions are required for the SAS Shigella Sonnei Form II Antiserum?

The product does not require special storage conditions beyond standard refrigeration. Proper refrigeration ensures stability and maintains its effectiveness for diagnostic use.

What regulatory pathway and clearance does the SAS Shigella Sonnei Form II Antiserum follow?

The antiserum holds an FDA 510(k) clearance under the Traditional review pathway, classified as a Class II device. It was granted clearance in 1996 under the product code GNB, with a decision description of 'Substantially Equivalent' to predicate devices.

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 SONNEI FORM II ANTISERUM - Innolitics, K961537 FDA 510(k) - SAS SHIGELLA SONNEI FORM II ANTISERUM, SAS SHIGELLA SONNEI FORM II ANTISERUM 510(k) K961537 - FDA.report, SAS SHIGELLA SONNEI FORM II ANTISERUM - Innolitics, Shigella - Anti-S. sonnei antiserum mixture: D - Bio-Rad

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) K961537 24 fields · synced Oct 1, 2026