Product Code: DDI
FDA class 2
21 CFR 866.5880
Transferrin, Fitc, Antigen, Antiserum, Control
Immunology
This is an immunological reagent kit for detecting and measuring transferrin using FITC as a fluorescent conjugate, providing antigen, antiserum, and control components for immunofluorescence-based analysis of this iron-transport protein in clinical specimens. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification, and is eligible for third-party review. The product code is DDI, regulated under 21 CFR 866.5880, within the Immunology specialty.
510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
6
Basic Information
- Product Code
- DDI
- Device Class
- FDA class 2
- Regulation Number
- 866.5880
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.