Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3660](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3660) → LIA — Antigens, All Groups, Shigella Spp.

# LIA · Antigens, All Groups, Shigella Spp.

_Microbiology · 21 CFR 866.3660 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LIA

## Overview

- **Product Code:** LIA
- **Device Name:** Antigens, All Groups, Shigella Spp.
- **Regulation:** [21 CFR 866.3660](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3660)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Shigella spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye (immunofluorescent reagents), used in serological tests to identify Shigella spp. from cultured isolates. The identification aids in the diagnosis of shigellosis caused by bacteria belonging to the genus Shigella and provides epidemiological information on this disease. Shigellosis is characterized by abdominal pain, cramps, diarrhea, and fever.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K813191](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LIA/K813191.md) | SHIGELLA SERA-CHEK | Lab Ability, Inc. | Dec 3, 1981 | SESE |

## Top Applicants

- Lab Ability, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LIA](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LIA)

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