21 CFR 862.1035 — Bromcresol Green Dye-Binding, Albumin
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1035
Identification
An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 | 120 | 3rd Party |
| CJF | Tetrabromophenolphthalein, Albumin | 2 | 1 | 3rd Party |
| CJG | Tetrabromo-M-Cresolsulfonphthalein, Albumin | 2 | 1 | 3rd Party |
| CJQ | Radial Immunodiffusion, Albumin | 2 | 1 | 3rd Party |
| CJW | Bromcresol Purple Dye-Binding, Albumin | 2 | 18 | 3rd Party |
| CJZ | Acid, Hydroxyazobenzene-Benzoic, Albumin | 2 | 0 | 3rd Party |
