← Product Code [CIG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG) · K905622

# COULTER DIRECT BILLRUBIN REAGENT (K905622)

_Coulter Electronics, Inc. · CIG · Dec 26, 1990 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG/K905622

## Device Facts

- **Applicant:** Coulter Electronics, Inc.
- **Product Code:** [CIG](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG.md)
- **Decision Date:** Dec 26, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1110
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG/K905622](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIG/K905622)

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