← Product Code [GTZ](/productcode/GTZ) · K860923

# EZ DETECT, 5 MINUTE STREP-A COLOR TEST (K860923)

_Self Care Systems, Inc. · GTZ · May 16, 1986 · Microbiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K860923

## Device Facts

- **Applicant:** Self Care Systems, Inc.
- **Product Code:** [GTZ](/productcode/GTZ.md)
- **Decision Date:** May 16, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3740
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory Identification

Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identify Streptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Streptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.

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**Source:** [https://fda-staging.innolitics.com/device/K860923](https://fda-staging.innolitics.com/device/K860923)

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