← Product Code [DDX](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX) · K772085

# LAS-R HUMAN PLASMINOGEN TEST (K772085)

_Hyland Therapeutic Div., Travenol Laboratories · DDX · Jan 24, 1978 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX/K772085

## Device Facts

- **Applicant:** Hyland Therapeutic Div., Travenol Laboratories
- **Product Code:** [DDX](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX.md)
- **Decision Date:** Jan 24, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5715
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

A plasminogen immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the plasminogen (an inactive substance from which plasmin, a blood-clotting factor, is formed) in serum, other body fluids, and tissues. Measurement of plasminogen levels may aid in the diagnosis of fibrinolytic (blood-clotting) disorders.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX/K772085](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX/K772085)

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