DGN · Breast Milk, Fitc, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5170 · Class 1
Overview
| Product Code | DGN |
|---|---|
| Device Name | Breast Milk, Fitc, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5170 |
| Device Class | Class 1 |
| Review Panel | Immunology |
Identification
A breast milk immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the breast milk proteins.
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.
