21 CFR 862.1170 — Electrode, Ion-Specific, Chloride
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1170
Identification
A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CGZ | Electrode, Ion-Specific, Chloride | 2 | 38 | 3rd Party |
| CHG | Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride | 2 | 3 | 3rd Party |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 2 | 53 | 3rd Party |
| CHK | Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride | 2 | 1 | 3rd Party |
| JFS | Coulometric, Chloride | 2 | 19 | 3rd Party |
