Sas Shigella Dysenteriae Type 9 Antiserum
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K961559 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 Dysenteriae Type 9 Antiserum is an antiserum preparation directed against Shigella dysenteriae type 9. It is classified under the FDA device category Antisera, All Types, Shigella spp. and is intended for use in microbiology applications related to the identification of this specific Shigella serotype.
The product is manufactured by Sa Scientific, Inc. and received traditional 510(k) clearance (K961559) as a Class II device with product code GNB. It was cleared on May 20, 1996, and is listed in the FDA registration database under the specified K number and registration numbers.
Frequently asked questions
What is the intended use of the SAS Shigella Dysenteriae Type 9 Antiserum?
It is intended for microbiology applications that involve the identification of Shigella dysenteriae type 9. The antiserum provides a specific reagent to detect this serotype in laboratory testing, supporting accurate diagnosis and epidemiologic investigations.
How was the SAS Shigella Dysenteriae Type 9 Antiserum cleared by the FDA?
The product received traditional 510(k) clearance (K961559) as a Class II device, indicating it was found substantially equivalent to a legally marketed predicate device. This clearance, issued on May 20 1996, allows it to be marketed for its specified microbiology use.
Is the SAS Shigella Dysenteriae Type 9 Antiserum supplied as a sterile, single‑use product?
The device is classified under the FDA category Antisera, All Types, Shigella spp., which are typically supplied in sterile, single‑use vials for laboratory use. This format ensures the reagent remains uncontaminated and maintains its specificity for each test.
What regulatory classification applies to this antiserum?
It is classified as a Class II device under the FDA device class for Antisera, All Types, Shigella spp., with product code GNB. Class II devices are subject to special controls, including performance standards and labeling requirements, to ensure safety and effectiveness.
Where can I find the manufacturer’s contact information for this product?
The manufacturer, Sa Scientific, Inc., is located at 4919 Golden Quail, San Antonio, TX 78240, United States. The listed contact person is Martin P O'Connor, which can be used for inquiries about ordering, technical support, or regulatory documentation.
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 DYSENTERIAE TYPE 9 ANTISERUM (K961559) — FDA 510(k ..., SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM 510(k)… - FDA.report, K953316 FDA 510(k) - SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ..., SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM by SA SCIENTIFIC, INC. | FDA ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K961559 | Class II | Active |
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Manufacturer
- Manufacturer
- Sa Scientific, Inc.
Sources (1)
- FDA 510(k) K961559 24 fields · synced Sep 23, 2026