Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3700](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3700) → LHJ — Staphylococcus Aureus Protein A Insoluble

# LHJ · Staphylococcus Aureus Protein A Insoluble

_Microbiology · 21 CFR 866.3700 · Class 1_

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

## Overview

- **Product Code:** LHJ
- **Device Name:** Staphylococcus Aureus Protein A Insoluble
- **Regulation:** [21 CFR 866.3700](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3700)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Staphylococcus aureus serological reagents are devices that consist of antigens and antisera used in serological tests to identify enterotoxin (toxin affecting the intestine) producing staphylococci from cultured isolates. The identification aids in the diagnosis of disease caused by this bacterium belonging to the genus Staphylococcus and provides epidemiological information on these diseases. Certain strains of Staphylococcus aureus produce an enterotoxin while growing in meat, dairy, or bakery products. After ingestion, this enterotoxin is absorbed in the gut and causes destruction of the intestinal lining (gastroenteritis).

## Classification Rationale

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

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K940557](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LHJ/K940557.md) | STAPHYTECT-OD | Unipath , Ltd. | Jul 28, 1994 | SESE |
| [K842709](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LHJ/K842709.md) | IMMUSTAPH LATEX AGGLUTINATION KIT | Immucell Corp. | Aug 3, 1984 | SESE |
| [K812181](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LHJ/K812181.md) | STAPHYLOCOCCAL PROTEIN A INSOLUBLE | Oxoid U.S.A., Inc. | Aug 25, 1981 | SESE |

## Top Applicants

- Immucell Corp. — 1 clearance
- Oxoid U.S.A., Inc. — 1 clearance
- Unipath , Ltd. — 1 clearance

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

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