NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM
Device Facts
| Record ID | K860138 |
|---|---|
| Device Name | NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM |
| Applicant | Sigma Diagnostics, Inc. |
| Product Code | DDB · Immunology |
| Decision Date | Mar 28, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5210 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
