DAL · Fraction Iv-5, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5360 · Class 1
Overview
| Product Code | DAL |
|---|---|
| Device Name | Fraction Iv-5, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5360 |
| Device Class | Class 1 |
| Review Panel | Immunology |
Identification
A Cohn fraction IV immunological test system is a device that consists of or measures that fraction of plasma proteins, predominantly alpha- and beta- globulins, used as a raw material for the production of pure alpha- or beta- globulins. Measurement of specific alpha- or beta- globulins aids in the diagnosis of many diseases, such as Wilson's disease (an inherited disease affecting the liver and brain), Tangier's disease (absence of alpha- 1-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease.
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 the limitations in § 866.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
