CHR · Titrimetric Phenol Red, Carbon-Dioxide
Clinical Chemistry · 21 CFR 862.1160 · Class 2
Overview
| Product Code | CHR |
|---|---|
| Device Name | Titrimetric Phenol Red, Carbon-Dioxide |
| Regulation | 21 CFR 862.1160 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Classification Rationale
Class II.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
