Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart F — Immunological Test Systems](/submissions/IM/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5200](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5200) → DDE — Carbonic Anhydrase C, Antigen, Antiserum, Control

# DDE · Carbonic Anhydrase C, Antigen, Antiserum, Control

_Immunology · 21 CFR 866.5200 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDE

## Overview

- **Product Code:** DDE
- **Device Name:** Carbonic Anhydrase C, Antigen, Antiserum, Control
- **Regulation:** [21 CFR 866.5200](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/866.5200)
- **Device Class:** 1
- **Review Panel:** [Immunology](/submissions/IM)

## 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](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDE/K902055.md) | TENONE(TM) OPIATES CATALOG: VKSO1,4 | Diagnostic Products Corp. | Jul 10, 1990 | SESE |
| [K823680](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDE/K823680.md) | COAT-A-COUNT MORPHINE KIT & COMPONENTS | Diagnostic Products Corp. | Jan 5, 1983 | SESE |
| [K820900](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDE/K820900.md) | EMIT URINE METHADONE ASSAY #3E319 | Syva Co. | Apr 26, 1982 | SESE |

## Top Applicants

- Diagnostic Products Corp. — 2 clearances
- Syva Co. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDE](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDE)

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