SAS Salmonella H L, Z13 Antiserum
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K955203 FDA 510(k)
- FDA Product Code
- GNC 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)
SAS Salmonella H L, Z13 Antiserum is an in vitro diagnostic reagent used for the serological identification of Salmonella species. It is designed to aid in the diagnosis of salmonellosis by detecting specific H (flagellar) and Z (phase 1 and 2) antigens in bacterial isolates. The antiserum supports clinical laboratories in differentiating Salmonella strains for epidemiological surveillance and patient management.
The device is supplied as a liquid reagent for use in slide and tube agglutination tests. It is intended for single use in microbiology settings and should be stored under refrigerated conditions as specified by the manufacturer. The product is regulated under Class II device classification with special controls, and its use is limited to laboratory personnel trained in serological techniques.
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 SALMONELLA H L,Z13 ANTISERUM by SA SCIENTIFIC, INC. | FDA 510 (k ..., SAS SALMONELLA H L,Z13 ANTISERUM (K955203) - FDA 510 (k), SAS SALMONELLA H L,V ANTISERUM (K955205) - FDA 510 (k), Sas Salmonella H Z Antiserum 510 (k) K955189 - FDA.report, SAS SALMONELLA H POLY A ANTISERUM - Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K955203 | Class II | Active |
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Manufacturer
- Manufacturer
- Sa Scientific, Inc.
Sources (1)
- FDA 510(k) K955203 24 fields · synced Sep 25, 2026