K-number	K252336
Device name	Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay
Applicant	Diazyme Laboratories, Inc.
Product code	—
Device class	Class unclassified
Decision date	Apr 24, 2026
Decision	Substantially Equivalent
Regulation	—

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

These are three immunoturbidimetric assays that quantitatively measure immunoglobulin levels (IgA, IgG, and IgM) in human serum. The assays aid in diagnosing abnormal protein metabolism and immune deficiencies by detecting the body's ability to resist infectious agents. All three are intended for in vitro diagnostic use only.

Technological characteristics

Not stated in this summary.

Test standards cited

The device is subject to Quality Management System Regulation (QMSR) requirements including ISO 13485 clauses for design controls, nonconforming product handling, corrective action, and preventative action.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay

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