← Product Code [JPE](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JPE) · K933125

# BERICHROM ANTITHROMBIN III (A) (K933125)

_Behring Diagnostics, Inc. · JPE · Apr 19, 1994 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JPE/K933125

## Device Facts

- **Applicant:** Behring Diagnostics, Inc.
- **Product Code:** [JPE](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JPE.md)
- **Decision Date:** Apr 19, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7060
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JPE/K933125](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JPE/K933125)

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