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- Subpart B—Biological StainsCFR Sub-Part
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- Subpart F—Immunological Test SystemsCFR Sub-Part
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Radioimmunoassay (Two-Site Solid Phase), Ferritin
- Page Type
- Product Code
- Regulation Medical Specialty
- Immunology
- Review Panel
- Chemistry
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 866.5340
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 866.5340 Ferritin immunological test system
§ 866.5340 Ferritin immunological test system.
(a) Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.
(b) Classification. Class II (performance standards).