← Product Code [CZP](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP) · K800211

# IMMUNOGLOBULIN A REAGENT SYSTEM (K800211)

_Calbiochem-Behring Corp. · CZP · Feb 19, 1980 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K800211

## Device Facts

- **Applicant:** Calbiochem-Behring Corp.
- **Product Code:** [CZP](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP.md)
- **Decision Date:** Feb 19, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5510
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K800211](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZP/K800211)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com