DEG · Lactoferrin, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5570 · Class 1
Overview
| Product Code | DEG |
|---|---|
| Device Name | Lactoferrin, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5570 |
| Device Class | Class 1 |
| Review Panel | Immunology |
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.
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.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K071712 | LEUKO EZ VUE | Techlab Inc., Corporate Research Center | Dec 4, 2007 | SESE |
| K042071 | IBD-SCAN | Techlab, Inc. | Oct 20, 2004 | SESE |
| K030704 | IBD-QUIK CHEK | Techlab, Inc. | Apr 21, 2003 | SESE |
| K011396 | IBD-CHEK | Techlab, Inc. | Jun 18, 2001 | SESE |
| K951101 | LEUKO-TEST | Techlab, Inc. | Apr 24, 1995 | SESE |
| K934473 | LACTOFERRIN MICROASSAY SYSTEM | Touch Scientific, Inc. | Dec 3, 1993 | SESE |
| K931901 | LACTOCARD | Touch Scientific, Inc. | Jul 6, 1993 | SESE |
| K852737 | LACTOPLATE | Mackeen Consultants, Ltd. | Oct 25, 1985 | SESE |
Top Applicants
- Techlab, Inc. — 4 clearances
- Touch Scientific, Inc. — 2 clearances
- Techlab Inc., Corporate Research Center — 1 clearance
- Mackeen Consultants, Ltd. — 1 clearance
