SAS Spicer-Edwards EN Complex Antiserum
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K955227 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 Spicer-Edwards EN Complex Antiserum is a Salmonella spp. serological reagent consisting of antigens and antisera used in serological tests to identify Salmonella spp. from cultured isolates derived from clinical specimens. It is classified as a Class II medical device under regulation number 866.3550 with product code GNC.
The device received FDA 510(k) clearance (K955227) on February 13, 1996, as substantially equivalent to a predicate device. It is manufactured by Sa Scientific, Inc. and is intended for use in microbiology laboratory settings for the identification of Salmonella species.
Frequently asked questions
What is SAS Spicer-Edwards EN Complex Antiserum used for?
SAS Spicer-Edwards EN Complex Antiserum is used in serological tests to identify Salmonella species from cultured isolates obtained from clinical specimens, aiding microbiology laboratories in bacterial identification.
How is SAS Spicer-Edwards EN Complex Antiserum supplied and stored?
The device is supplied as a serological reagent containing antigens and antisera for laboratory use; specific storage conditions are not detailed in the provided data, but it is intended for use in microbiology laboratory settings.
Is SAS Spicer-Edwards EN Complex Antiserum reusable or single-use?
The provided data does not specify whether the reagent is single-use or reusable; however, as a laboratory reagent for serological testing, it is typically consumed during use and not intended for reuse.
What regulatory pathway was used for SAS Spicer-Edwards EN Complex Antiserum?
SAS Spicer-Edwards EN Complex Antiserum received FDA 510(k) clearance (K955227) on February 13, 1996, as substantially equivalent to a predicate device under regulation number 866.3550.
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 SPICER-EDWARDS EN COMPLEX ANTISERUM by SA SCIENTIFIC, INC. | FDA ..., SAS SPICER-EDWARDS EN COMPLEX ANTISERUM (K955227) — FDA 510 (k ..., K955227 FDA 510(k) - SAS SPICER-EDWARDS EN COMPLEX ANTISERUM, Sas Spicer-edwards En Complex Antiserum 510(k) K955227 - 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 | K955227 | Class II | Active |
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Manufacturer
- Manufacturer
- Sa Scientific, Inc.
Sources (1)
- FDA 510(k) K955227 24 fields · synced Oct 1, 2026