21 CFR 862.1310 — Enzymatic Methods, Galactose
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1310
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JIA | Enzymatic Methods, Galactose | 1 | 9 | 3rd Party |
| JIB | U.V. Method, Galactose | 1 | 0 | 3rd Party |
| JIC | Colorimetric Method, Galactose | 1 | 0 | 3rd Party |
