Salmonella 0 Group M Factor 28 Antiserum
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K960160 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 Salmonella 0 Group M Factor 28 Antiserum is an antisera used in microbiology. It is designed to react with Salmonella spp.
The antisera is supplied by Sa Scientific, Inc. and has been cleared with a Traditional 510K clearance. It is classified as a device class 2 product, with the regulation number 866.3550, and is registered with the FDA.
Frequently asked questions
What is the Salmonella 0 Group M Factor 28 Antiserum used for?
The Salmonella 0 Group M Factor 28 Antiserum is used in microbiology to react with Salmonella spp.
How is the Salmonella 0 Group M Factor 28 Antiserum supplied?
The antisera is supplied by Sa Scientific, Inc.
What is the regulatory classification of the Salmonella 0 Group M Factor 28 Antiserum?
The Salmonella 0 Group M Factor 28 Antiserum is classified as a device class 2 product with the 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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K960160 | Class II | Active |
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Manufacturer
- Manufacturer
- Sa Scientific, Inc.
Sources (1)
- FDA 510(k) K960160 24 fields · synced Sep 23, 2026