LEUKO-TEST
Device Facts
| Record ID | K951101 |
|---|---|
| Device Name | LEUKO-TEST |
| Applicant | Techlab, Inc. |
| Product Code | DEG · Immunology |
| Decision Date | Apr 24, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5570 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A lactoferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the lactoferrin (an iron-binding protein with the ability to inhibit the growth of bacteria) in serum, breast milk, other body fluids, and tissues. Measurement of lactoferrin may aid in the diagnosis of an inherited deficiency of this protein.
