Antigens, All Groups, Shigella Spp.
Shigella spp. all-group antigens are microbiological reagents containing antigens from all serological groups of Shigella bacteria, used in agglutination and serotyping tests to identify Shigella species isolated from patient specimens in the laboratory diagnosis of shigellosis (bacillary dysentery). The device is FDA Class 2, indicating moderate risk and does not require a 510(k) in this classification scenario. It carries product code LIA and is regulated under 21 CFR 866.3660 within the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LIA
- Device Class
- FDA class 2
- Regulation Number
- 866.3660
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K813191 | SHIGELLA SERA-CHEK | Dec 03, 1981 | Substantially Equivalent | Lab Ability, Inc. |