Cytomegalovirus Indirect Immunofluorescence Assay

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K935809 ↗

FDA Product Code

GQH

Device Class

Class II

Regulation

21 CFR Part 866.3175

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the Cytomegalovirus Indirect Immunofluorescence Assay used for?

  This assay detects the lower matrix protein pp65 of human cytomegalovirus (CMV) in cytospin preparations of peripheral blood leukocytes. It supports the diagnosis of CMV infection by identifying CMV antigenemia in clinical samples, which is particularly useful for managing patients who are immunocompromised or at high risk for CMV-related complications.

• How is the Cytomegalovirus Indirect Immunofluorescence Assay supplied?

  The assay is supplied as a single-use diagnostic reagent kit. It is designed for use in sterile laboratory settings by trained personnel, ensuring controlled and consistent testing conditions for accurate results.

• Is the Cytomegalovirus Indirect Immunofluorescence Assay sterile?

  Yes, the assay is intended for use in sterile laboratory settings. While the kit itself is not explicitly labeled as sterile packaging, its design and intended use require adherence to standard virology assay protocols to maintain sterility and assay integrity during handling and testing.

• Can the Cytomegalovirus Indirect Immunofluorescence Assay be reused?

  No, the assay is explicitly designed as a single-use diagnostic reagent kit. Reuse is not recommended as it could compromise the accuracy and reliability of the results due to potential contamination or degradation of the reagents.

• What regulatory pathway does the Cytomegalovirus Indirect Immunofluorescence Assay follow?

  The assay is regulated under the FDA 510(k) clearance pathway, specifically with clearance number K935809. It falls under Special Controls for microbiology applications and is classified under product code GQH as an Antigen, Cf (Including Cf Control), Cytomegalovirus, categorized as a Class II device.