JQM · P-Bromoaniline, Xylose
Clinical Chemistry · 21 CFR 862.1820 · Class 1
Overview
| Product Code | JQM |
|---|---|
| Device Name | P-Bromoaniline, Xylose |
| Regulation | 21 CFR 862.1820 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A xylose test system is a device intended to measure xylose (a sugar) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption syndrome (a group of disorders in which there is subnormal absorption of dietary constituents and thus excessive loss from the body of the nonabsorbed substances).
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.
