← Product Code [CFN](/productcode/CFN) · K771226

# LAS-R TEST PROGRAM (K771226)

_Hyland Therapeutic Div., Travenol Laboratories · CFN · Jul 21, 1977 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K771226

## Device Facts

- **Applicant:** Hyland Therapeutic Div., Travenol Laboratories
- **Product Code:** [CFN](/productcode/CFN.md)
- **Decision Date:** Jul 21, 1977
- **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/device/K771226](https://fda.innolitics.com/device/K771226)

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