21 CFR 866.5200 — Carbonic Anhydrase C, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5200
Identification
A carbonic anhydrase B and C immunological test system is a device that consists of the reagents used to measure by immunochemical techniques specific carbonic anhydrase protein molecules in serum and other body fluids. Measurements of carbonic anhydrase B and C aid in the diagnosis of abnormal hemoglobin metabolism.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DDE | Carbonic Anhydrase C, Antigen, Antiserum, Control | 1 | 3 | |
| DDH | Carbonic Anhydrase B, Antigen, Antiserum, Control | 1 | 0 | |
| KTK | Reagent, Immunoassay, Carbonic Anhydrase B And C | 1 | 0 |
