Fiax Toxo-M Antibodies Test Kit

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K850591 ↗

FDA Product Code

GLZ

Device Class

Class II

Regulation

21 CFR Part 866.3780

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the Fiax Toxo-M Antibodies Test Kit used for?

  The Fiax Toxo-M Antibodies Test Kit is an in vitro diagnostic device designed to detect IgM and IgG antibodies in human serum or plasma. It aids in diagnosing toxoplasmosis by identifying immune responses to *Toxoplasma gondii*, the parasite responsible for the infection. This helps clinicians confirm exposure or active infection based on antibody presence.

• How is the Fiax Toxo-M Antibodies Test Kit supplied and intended for use?

  The kit is supplied as a single-use diagnostic tool, meaning each test requires a new kit. It is intended exclusively for use in microbiology laboratories, where trained personnel can perform the assay under controlled conditions. The design ensures accuracy and reliability for clinical decision-making.

• Does the Fiax Toxo-M Antibodies Test Kit require special storage?

  No special storage conditions are required beyond standard refrigeration. The kit should be stored at temperatures between 2°C and 8°C to maintain its integrity and performance. Avoid freezing or exposure to extreme temperatures, as this could compromise the test components.

• Is the Fiax Toxo-M Antibodies Test Kit reusable or single-use?

  The Fiax Toxo-M Antibodies Test Kit is explicitly designed for single-use only. Each kit is intended for one diagnostic test to ensure accuracy and prevent cross-contamination. Discard any unused portions after testing to comply with regulatory and safety standards.

• What regulatory pathway does the Fiax Toxo-M Antibodies Test Kit follow?

  The kit follows the traditional 510(k) review pathway under FDA regulation number 866.3780. It was cleared in 1985 and remains compliant with the original submission standards. The product code GLZ categorizes it under microbiology diagnostics, ensuring it meets established safety and performance criteria for in vitro antibody testing.