JMN · Extraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline
Clinical Chemistry · 21 CFR 862.1400 · Class 1
Overview
| Product Code | JMN |
|---|---|
| Device Name | Extraction Plus Chromatography With Color By Ninhydrin, Hydroxyproline |
| Regulation | 21 CFR 862.1400 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.
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.
