← Product Code [KTS](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTS) · K781070

# SECOND ANTIBODY (K781070)

_Pcl-Ria, Inc. · KTS · Aug 10, 1978 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTS/K781070

## Device Facts

- **Applicant:** Pcl-Ria, Inc.
- **Product Code:** [KTS](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTS.md)
- **Decision Date:** Aug 10, 1978
- **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.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTS/K781070](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/KTS/K781070)

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