← Product Code [JCO](/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCO) · K955115

# VENOM TIEM REAGENT (K955115)

_Medical Diagnostic Technologies, Inc. · JCO · Apr 3, 1996 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCO/K955115

## Device Facts

- **Applicant:** Medical Diagnostic Technologies, Inc.
- **Product Code:** [JCO](/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCO.md)
- **Decision Date:** Apr 3, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.8100
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A Bothrops atrox reagent is a device made from snake venom and used to determine blood fibrinogen levels to aid in the evaluation of disseminated intravascular coagulation (nonlocalized clotting in the blood vessels) in patients receiving heparin therapy (the administration of the anticoagulant heparin in the treatment of thrombosis) or as an aid in the classification of dysfibrinogenemia (presence in the plasma of functionally defective fibrinogen).

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCO/K955115](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCO/K955115)

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