DDH · Carbonic Anhydrase B, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5200 · Class 1
Overview
| Product Code | DDH |
|---|---|
| Device Name | Carbonic Anhydrase B, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5200 |
| Device Class | Class 1 |
| Review Panel | Immunology |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
