← Product Code [DCE](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCE) · K772128

# FLUORESCEIN CONJUGATED (K772128)

_Kallestad Laboratories, Inc. · DCE · Nov 22, 1977 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCE/K772128

## Device Facts

- **Applicant:** Kallestad Laboratories, Inc.
- **Product Code:** [DCE](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCE.md)
- **Decision Date:** Nov 22, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5520
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCE/K772128](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DCE/K772128)

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