Sas Shigella Boydii Group C1/C1 (8-10) Antiserum
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K961546 FDA 510(k)
- FDA Product Code
- GNB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3660 FDA 510(k)
- Regulation Number
- 866.3660 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sas Shigella Boydii Group C1/C1 (8-10) Antiserum is a serological reagent used for the identification of Shigella species. It consists of specific antisera designed to detect and identify these bacteria.
This device is classified as a Class II medical device under regulation number 866.3660 and product code GNB. It received FDA 510(k) clearance under K961546 on May 20, 1996.
Frequently asked questions
What is the primary use of the SAS Shigella Boydii Group C1/C1 (8-10) Antiserum?
This product is a serological reagent specifically designed for the identification of Shigella species. It allows laboratory professionals to detect and identify these bacteria through specific antigen-antibody reactions.
What is the regulatory status of this antiserum?
The SAS Shigella Boydii Group C1/C1 (8-10) Antiserum is a Class II medical device regulated under 866.3660. It received FDA 510(k) clearance on May 20, 1996, under submission number K961546.
Which product code is associated with this device?
This device is categorized under product code GNB, which corresponds to antisera used for the identification of Shigella species within the microbiology medical specialty.
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 Shigella Boydii Group C1/C1 (8-10) Antiserum, K961546 FDA 510(k) - SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ..., K961546 FDA 510(k) - SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ..., SAS SHIGELLA BOYDII TYPE 8 ANTISERUM by SA SCIENTIFIC, INC. | FDA 510 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K961546 | Class II | Active |
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Manufacturer
- Manufacturer
- Sa Scientific, Inc.
Sources (1)
- FDA 510(k) K961546 24 fields · synced Sep 27, 2026