← Product Code [JIR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR) · K912543

# MICRO ALBUMIN EIA TEST KIT (K912543)

_Immuno Diagnostic Center, Inc. · JIR · Jul 19, 1991 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR/K912543

## Device Facts

- **Applicant:** Immuno Diagnostic Center, Inc.
- **Product Code:** [JIR](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR.md)
- **Decision Date:** Jul 19, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1645
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR/K912543](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIR/K912543)

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