← Product Code [JTL](/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTL) · K950706

# DRYSLIDE COAGULASE (K950706)

_Difco Laboratories, Inc. · JTL · May 16, 1995 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTL/K950706

## Device Facts

- **Applicant:** Difco Laboratories, Inc.
- **Product Code:** [JTL](/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTL.md)
- **Decision Date:** May 16, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.2160
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Regulatory Identification

Coagulase plasma is a device that consists of freeze-dried animal or human plasma that is intended for medical purposes to perform coagulase tests primarily on staphylococcal bacteria. When reconstituted, the fluid plasma is clotted by the action of the enzyme coagulase which is produced by pathogenic staphylococci. Test results are used primarily as an aid in the diagnosis of disease caused by pathogenic bacteria belonging to the genus Staphylococcus and provide epidemiological information on disease caused by these microorganisms.

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTL/K950706](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JTL/K950706)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com