21 CFR 866.5640 — System, Test, Infectious Mononucleosis
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5640
Identification
An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KTN | System, Test, Infectious Mononucleosis | 2 | 59 | 3rd Party |
