21 CFR 862.1040 — Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1040
Identification
An aldolase test system is a device intended to measure the activity of the enzyme aldolase in serum or plasma. Aldolase measurements are used in the diagnosis and treatment of the early stages of acute hepatitis and for certain muscle diseases such as progressive Duchenne-type muscular dystrophy.
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CJC | Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase | 1 | 0 | |
| CJT | Hydrazone Colorimetry, Aldolase | 1 | 1 |
