21 CFR 866.5065 — Ng1m(A), Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5065
Identification
A human allotypic marker immunological test system is a device that consists of the reagents used to identify by immunochemical techniques the inherited human protein allotypic markers (such as nGm, nA2 m, and Km allotypes) in serum and other body fluids. The identification may be used while studying population genetics.
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 § 866.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DGX | Ng1m(A), Antigen, Antiserum, Control | 1 | 1 | |
| DHF | D/Km-1, Antigen, Antiserum, Control | 1 | 1 | |
| DHI | Ng3m(Bo), Antigen, Antiserum, Control | 1 | 1 | |
| DHQ | Ng3m(G), Antigen, Antiserum, Control | 1 | 0 | |
| DHY | Ng4m(A), Antigen, Antiserum, Control | 1 | 1 |
