← Product Code [DDF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDF) · K812985

# AGGLUTEX MORPHINE TEST KIT (K812985)

_Hoffmann-La Roche, Inc. · DDF · Dec 31, 1981 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-f%E2%80%94immunological-test-systems/DDF/K812985

## Device Facts

- **Applicant:** Hoffmann-La Roche, Inc.
- **Product Code:** [DDF](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDF.md)
- **Decision Date:** Dec 31, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5735
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

A prothrombin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prothrombin (clotting factor II) in serum. Measurements of the amount of antigenically competent (ability to react with protein antibodies) prothrombin aid in the diagnosis of blood-clotting disorders.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-f%E2%80%94immunological-test-systems/DDF/K812985](https://fda.innolitics.com/submissions/TX/subpart-f%E2%80%94immunological-test-systems/DDF/K812985)

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