Product Code: DFD
FDA class 2
21 CFR 866.5550
Kappa, Peroxidase, Antigen, Antiserum, Control
Immunology
This is an immunological reagent kit for detecting the kappa light chain of immunoglobulins using peroxidase as an enzymatic conjugate, including antigen, antiserum, and control components for enzyme-linked immunoassay applications. Kappa light chain analysis is used in clinical evaluation of plasma cell neoplasms and monoclonal gammopathy. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DFD, regulated under 21 CFR 866.5550, within the Immunology specialty.
510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
1
Years Active
4
Basic Information
- Product Code
- DFD
- Device Class
- FDA class 2
- Regulation Number
- 866.5550
- Medical Specialty
- Immunology
- Review Panel
- PA
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K940242 | VENTANA CEA PRIMARY ANTIBODY | Dec 23, 1996 | Substantially Equivalent | VENTANA MEDICAL SYSTEMS, INC. |
| K924578 | PSA ANTIBODY KIT | Feb 05, 1993 | Substantially Equivalent | VENTANA MEDICAL SYSTEMS, INC. |
| K924629 | PAP ANTIBODY KIT | Feb 04, 1993 | Substantially Equivalent | VENTANA MEDICAL SYSTEMS, INC. |