Immunochemical, Transferrin
The Immunochemical, Transferrin test is an in vitro diagnostic device used to quantify transferrin, an iron-transport protein, in serum or other biological fluids using immunochemical methods. Transferrin measurements are used in the evaluation of iron deficiency, iron overload conditions, nutritional status, and liver function. This device is FDA Class 2, a moderate risk designation requiring 510(k) premarket notification prior to marketing. It carries product code JNM and is regulated under 21 CFR 866.5880, within the Immunology medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- JNM
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K992188 | NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028 | Dec 06, 1999 | Substantially Equivalent | Nichols Institute Diagnostics |
| K981208 | TFR | Oct 21, 1998 | Substantially Equivalent | Ramco Laboratories, Inc. |
| K970718 | QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) | May 27, 1997 | Substantially Equivalent | R&D Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.