Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1790](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1790) → JQL — Spectrophotometric, Uroporphyrin

# JQL · Spectrophotometric, Uroporphyrin

_Clinical Chemistry · 21 CFR 862.1790 · Class 1_

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

## Overview

- **Product Code:** JQL
- **Device Name:** Spectrophotometric, Uroporphyrin
- **Regulation:** [21 CFR 862.1790](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1790)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A uroporphyrin test system is a device intended to measure uroporphyrin in urine. Measurements obtained by this device are used in the diagnosis and treatment of porphyrias (primarily inherited diseases associated with disturbed porphyrin metabolism), lead poisoning, and other diseases characterized by alterations in the heme pathway.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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