Lactoferrin, Antigen, Antiserum, Control
This is an immunological reagent kit for detecting lactoferrin, an iron-binding glycoprotein found in secretions and neutrophil granules with antimicrobial and immunomodulatory properties, including antigen, antiserum, and control components for clinical laboratory immunoassay applications. It is classified as FDA Class 1, the lowest risk category, subject to general controls only and not requiring premarket notification. The product code is DEG, regulated under 21 CFR 866.5570, within the Immunology specialty.
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Basic Information
- Product Code
- DEG
- Device Class
- FDA class 1
- Regulation Number
- 866.5570
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K071712 | LEUKO EZ VUE | Dec 04, 2007 | Substantially Equivalent | Techlab Inc., Corporate Research Center |
| K042071 | IBD-SCAN | Oct 20, 2004 | Substantially Equivalent | Techlab, Inc. |
| K030704 | IBD-QUIK CHEK | Apr 21, 2003 | Substantially Equivalent | Techlab, Inc. |
| K011396 | IBD-CHEK | Jun 18, 2001 | Substantially Equivalent | Techlab, Inc. |
| K951101 | LEUKO-TEST | Apr 24, 1995 | Substantially Equivalent | Techlab, Inc. |
| K934473 | LACTOFERRIN MICROASSAY SYSTEM | Dec 03, 1993 | Substantially Equivalent | Touch Scientific, Inc. |
| K931901 | LACTOCARD | Jul 06, 1993 | Substantially Equivalent | Touch Scientific, Inc. |
| K852737 | LACTOPLATE | Oct 25, 1985 | Substantially Equivalent | Mackeen Consultants, Ltd. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.