DDE · Carbonic Anhydrase C, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5200 · Class 1
Overview
| Product Code | DDE |
|---|---|
| Device Name | Carbonic Anhydrase C, 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K902055 | TENONE(TM) OPIATES CATALOG: VKSO1,4 | Diagnostic Products Corp. | Jul 10, 1990 | SESE |
| K823680 | COAT-A-COUNT MORPHINE KIT & COMPONENTS | Diagnostic Products Corp. | Jan 5, 1983 | SESE |
| K820900 | EMIT URINE METHADONE ASSAY #3E319 | Syva Co. | Apr 26, 1982 | SESE |
Top Applicants
- Diagnostic Products Corp. — 2 clearances
- Syva Co. — 1 clearance
