Identifiers
- 510(k) Number
- K955208 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)
The SAS Salmonella H H Antiserum is a diagnostic reagent classified as an Antigens, Febrile, Slide and Tube, All Groups, Salmonella spp. It is designed for use in serological testing to identify antibodies against Salmonella bacteria, aiding in the identification and epidemiological tracking of salmonellosis infections. This antiserum facilitates slide agglutination and tube agglutination assays to detect specific Salmonella serotypes, particularly those associated with febrile illnesses.
This product is supplied as a liquid reagent for microbiological laboratory use and is intended for single-use applications. It is regulated under FDA 510(k) clearance (K955208) and falls under Class II device classification (special controls) for microbiology diagnostics. Storage conditions and sterility are not specified in the data, but it is distributed under the product code GNC for use in clinical microbiology settings. No additional regulatory approvals beyond the stated 510(k) clearance are mentioned.
Frequently asked questions
What is the SAS Salmonella H H Antiserum used for in a clinical setting?
The SAS Salmonella H H Antiserum is a diagnostic reagent used in serological testing to identify antibodies against *Salmonella* bacteria. It aids in detecting specific *Salmonella* serotypes through slide agglutination and tube agglutination assays, helping to diagnose and track infections linked to febrile illnesses. It’s specifically designed for microbiology laboratories to support epidemiological investigations of salmonellosis.
Is this product meant for single-use or can it be reused?
The SAS Salmonella H H Antiserum is explicitly supplied as a liquid reagent for single-use applications in microbiological laboratories. Reuse is not recommended or supported by the manufacturer’s stated specifications.
What regulatory pathway does this device follow, and how is it classified?
This product follows the FDA’s 510(k) clearance pathway and is classified as a Class II medical device under special controls for microbiology diagnostics. It was granted substantial equivalence (SESE) by the FDA’s Microbiology (MI) Advisory Committee in 1996, with clearance number K955208. The device falls under product code GNC for use in clinical microbiology settings.
How is the SAS Salmonella H H Antiserum supplied, and what form does it take?
The SAS Salmonella H H Antiserum is supplied as a liquid reagent, intended exclusively for microbiological laboratory use. It comes ready-to-use in its liquid form, requiring no additional preparation before performing slide or tube agglutination tests for *Salmonella* detection.
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 H ANTISERUM (K955208) — FDA 510(k) | Innolitics, SAS SALMONELLA H H ANTISERUM (K955208) - FDA 510 (k), PDF K955208 - SAS SALMONELLA H H ANTISERUM - 510kdatabase.net, SAS SALMONELLA H POLY A ANTISERUM by SA SCIENTIFIC, INC. | FDA 510(k ..., Sas Salmonella H T Antiserum 510 (k) K955192 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K955208 | Class II | Active |
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Manufacturer
- Manufacturer
- Sa Scientific, Inc.
Sources (1)
- FDA 510(k) K955208 24 fields · synced Sep 20, 2026