Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3740](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3740) → MDK — Dna-Probe, Reagents, Streptococcal

# MDK · Dna-Probe, Reagents, Streptococcal

_Microbiology · 21 CFR 866.3740 · Class 1_

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

## Overview

- **Product Code:** MDK
- **Device Name:** Dna-Probe, Reagents, Streptococcal
- **Regulation:** [21 CFR 866.3740](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3740)
- **Device Class:** 1
- **Review Panel:** [Microbiology](/submissions/MI)

## 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.

## 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 § 866.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K974572](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MDK/K974572.md) | GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 | Chugai Pharmaceuticals Co., Ltd. | Sep 24, 1998 | SESE |
| [K924715](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MDK/K924715.md) | GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST | Gen-Probe, Inc. | Mar 11, 1994 | SESE |
| [K915852](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MDK/K915852.md) | ACCUPACE GROUP A STREPTOCOCCUS ID TEST | Gen-Probe, Inc. | Apr 2, 1992 | SESE |
| [K904268](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/MDK/K904268.md) | ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM. | Gen-Probe, Inc. | Nov 13, 1990 | SESE |

## Top Applicants

- Gen-Probe, Inc. — 3 clearances
- Chugai Pharmaceuticals Co., Ltd. — 1 clearance

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

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