21 CFR 866.5700 — Whole Blood Plasma, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5700
Identification
A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by immunochemical techniques the proteins in plasma or serum. Measurements of proteins in plasma or serum aid in the diagnosis of any disease concerned with abnormal levels of plasma or serum proteins, e.g., agammaglobulinemia, allergies, multiple myeloma, rheumatoid vasculitis, or hereditary angioneurotic edema.
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DGQ | Whole Blood Plasma, Antigen, Antiserum, Control | 1 | 1 | |
| DGR | Whole Human Serum, Antigen, Antiserum, Control | 1 | 5 |
