21 CFR 862.1515 — 2,4-Dinitrofluorobenzene (Spectroscopic), Nitrogen (Amino-Nitrogen)
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1515
Identification
A nitrogen (amino-nitrogen) test system is a device intended to measure amino acid nitrogen levels in serum, plasma, and urine. Nitrogen (amino-nitrogen) measurements are used in the diagnosis and treatment of certain forms of severe liver disease and renal disorders.
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 the limitations in § 862.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JMW | 2,4-Dinitrofluorobenzene (Spectroscopic), Nitrogen (Amino-Nitrogen) | 1 | 0 | |
| JMX | Ninhydrin, Nitrogen (Amino-Nitrogen) | 1 | 2 | |
| JQH | Trinitrobenzene Sulfonate (Spectroscopic), Nitrogen (Amino-Nitrogen) | 1 | 0 |
