← Product Code [KXT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KXT) · K972794

# DIGOXIN DG-II FPIA REAGENT SET (K972794)

_Sigma Diagnostics, Inc. · KXT · Jul 31, 1997 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KXT/K972794

## Device Facts

- **Applicant:** Sigma Diagnostics, Inc.
- **Product Code:** [KXT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KXT.md)
- **Decision Date:** Jul 31, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3320
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KXT/K972794](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KXT/K972794)

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