← Product Code [DAQ](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAQ) · K891299

# MID-LEVEL IGG KIT CAT. NO. 9315 (K891299)

_Helena Laboratories · DAQ · Mar 22, 1989 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAQ/K891299

## Device Facts

- **Applicant:** Helena Laboratories
- **Product Code:** [DAQ](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAQ.md)
- **Decision Date:** Mar 22, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5540
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

An immunoglobulin G (Fd fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the amino terminal (antigen-binding) end (Fd fragment) of the heavy chain (a subunit) of the immunoglobulin antibody molecule in serum. Measurement of immunoglobulin G Fd fragments aids in the diagnosis of plasma antibody-forming cell abnormalities.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAQ/K891299](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DAQ/K891299)

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