21 CFR 866.5210 — Immunochemical, Ceruloplasmin
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5210
Identification
A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CHN | Immunochemical, Ceruloplasmin | 2 | 3 | |
| DCT | Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control | 2 | 0 | |
| DCY | Ceruloplasmin, Fitc, Antigen, Antiserum, Control | 2 | 0 | |
| DDB | Ceruloplasmin, Antigen, Antiserum, Control | 2 | 19 | |
| JFQ | P-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin | 2 | 0 | |
| JFR | Indirect Copper Assay, Ceruloplasmin | 2 | 2 |
Special Controls
CHN — Immunochemical, Ceruloplasmin
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
eCFR
DCT — Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
eCFR
DCY — Ceruloplasmin, Fitc, Antigen, Antiserum, Control
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
eCFR
DDB — Ceruloplasmin, Antigen, Antiserum, Control
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
eCFR
JFQ — P-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
eCFR
JFR — Indirect Copper Assay, Ceruloplasmin
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
eCFR
