21 CFR 866.5060 — Prealbumin, Fitc, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5060
Identification
A prealbumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prealbumin (a plasma protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.
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 |
|---|---|---|---|---|
| DDS | Prealbumin, Fitc, Antigen, Antiserum, Control | 1 | 4 | |
| JZJ | Prealbumin, Antigen, Antiserum, Control | 1 | 11 |
