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SAS Salmonella H Z15 Antiserum

FDA 510(k)

Class II (US FDA 510(k))

510(k) K960610

by Sa Scientific, Inc.

Identifiers

510(k) Number
K960610 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 Z15 Antiserum is a diagnostic antisera product designed for the identification of Salmonella species. Classified under the nomenclature category Antisera, All Groups, Salmonella Spp., it is intended for microbiological testing to detect specific serological markers associated with Salmonella bacteria, aiding in laboratory diagnostics for infectious disease identification.

This product is supplied as a sterile liquid for in vitro diagnostic use, intended for single-use in microbiology laboratories. It is regulated under FDA 510(k) clearance (K960610) with a classification of Class II under Special Controls (Regulation 866.3550). The device is intended for use in microbiological testing environments and requires proper storage as specified by the manufacturer to maintain efficacy.

Frequently asked questions

What is the SAS Salmonella H Z15 Antiserum used for?

The SAS Salmonella H Z15 Antiserum is designed specifically for microbiological testing to identify Salmonella species. It detects serological markers associated with these bacteria, helping laboratories confirm infectious disease diagnoses. This is particularly useful in clinical microbiology settings where rapid and accurate identification of Salmonella is critical for patient management.

How is the SAS Salmonella H Z15 Antiserum supplied and intended for use?

This product is supplied as a sterile liquid, formulated exclusively for in vitro diagnostic use. It is intended for single-use only in microbiology laboratories. The sterile formulation ensures safety and reliability when performing serological tests, while the single-use designation helps prevent contamination and ensures consistent results.

Is the SAS Salmonella H Z15 Antiserum reusable, or is it meant for one-time use?

The SAS Salmonella H Z15 Antiserum is explicitly designed for single-use only. This is a standard practice for diagnostic antisera to maintain sterility, accuracy, and prevent cross-contamination between tests. Reusing antisera can compromise diagnostic integrity and pose safety risks in laboratory settings.

What regulatory clearance does the SAS Salmonella H Z15 Antiserum hold?

The SAS Salmonella H Z15 Antiserum has received FDA 510(k) clearance under the classification of Class II, with Special Controls under Regulation 866.3550. This clearance confirms that the device meets established performance standards and is substantially equivalent to a legally marketed predicate device, ensuring its safety and effectiveness for detecting Salmonella species in microbiological testing.

How should the SAS Salmonella H Z15 Antiserum be stored to maintain its efficacy?

While the exact storage instructions are not detailed in the provided data, most sterile liquid diagnostic reagents like this require refrigeration (typically between 2°C and 8°C) and protection from light to preserve stability and sterility. Always follow the manufacturer’s specific storage guidelines, which are usually included in the product labeling or accompanying documentation, to ensure optimal performance and longevity.

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: K960610 FDA 510 (k) - SAS SALMONELLA H Z15 ANTISERUM, SAS SALMONELLA H Z15 ANTISERUM (K960610) — FDA 510 (k) | Innolitics, SAS SALMONELLA H Z15 ANTISERUM 510 (k) K960610 - FDA.report

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) K960610 24 fields · synced Oct 1, 2026