Transferrin, Rhodamine, Antigen, Antiserum, Control
This is an immunological reagent kit for detecting transferrin, the plasma glycoprotein that transports iron in the bloodstream, using rhodamine as a fluorescent conjugate, including antigen, antiserum, and control components for immunofluorescence-based measurement. Transferrin levels are used to assess iron status and diagnose iron deficiency or overload conditions. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DDD, regulated under 21 CFR 866.5880, within the Immunology specialty.
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Basic Information
- Product Code
- DDD
- Device Class
- FDA class 2
- Regulation Number
- 866.5880
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K963139 | OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT | Feb 06, 1997 | Substantially Equivalent | Olympus America, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.