21 CFR 862.1330 — Electrophoretic, Globulin
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1330
Identification
A globulin test system is a device intended to measure globulins (proteins) in plasma and serum. Measurements of globulin are used in the diagnosis and treatment of patients with numerous illnesses including severe liver and renal disease, multiple myeloma, and other disorders of blood globulins.
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CGH | Electrophoretic, Globulin | 1 | 0 | |
| JGC | Tryptophan Measurement (Colorimetric), Globulin | 1 | 0 | |
| JGD | Nephelometric Method, Globulin | 1 | 0 | |
| JGE | Turbidimetric Method, Globulin | 1 | 1 |
