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 862.1310](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1310) → JIB — U.V. Method, Galactose

# JIB · U.V. Method, Galactose

_Clinical Chemistry · 21 CFR 862.1310 · Class 1_

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

## Overview

- **Product Code:** JIB
- **Device Name:** U.V. Method, Galactose
- **Regulation:** [21 CFR 862.1310](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1310)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## Identification

A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.

## Classification Rationale

Class I.

## 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/JIB](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIB)

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