CMV RQ Bio-Enzabead Kit

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K831343 ↗

FDA Product Code

LFZ

Device Class

Class II

Regulation

21 CFR Part 866.3175

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Toxo Bio-Bead Screen Kit

  Class II

  FDA 510(k) K791611 Active Cleared 13 Nov 1979

• Hsv Bio-Bead Screen Kit

  Class II

  FDA 510(k) K791614 Active Cleared 13 Nov 1979

• Hsv Bio-Bead Titration Kit

  Class II

  FDA 510(k) K801721 Active Cleared 16 Sep 1980

• Rubella Rq Bio-Enzabead Kit

  Class II

  FDA 510(k) K821804 Active Cleared 14 Sep 1982

• Cmv Bio-Bead Screen Kit

  Class II

  FDA 510(k) K791612 Active Cleared 13 Nov 1979

• Eb-Vca, Test, Antibody, Fluorescent

  Class I

  FDA 510(k) K780925 Active Cleared 22 Jun 1978

See all devices from Litton Bionetics →

• What is the CMV RQ Bio-Enzabead Kit used for?

  The CMV RQ Bio-Enzabead Kit is an enzyme-linked immunosorbent assay (ELISA) designed to detect and quantify immunoglobulin (Ig) antibodies against cytomegalovirus (CMV) in human serum or plasma. It helps clinicians assess whether a patient has been exposed to CMV or has developed immunity, supporting serological diagnosis in microbiology laboratories.

• How is the CMV RQ Bio-Enzabead Kit supplied and prepared for use?

  The kit is supplied as a single-use diagnostic reagent, meaning each kit is intended for one-time use only. No additional sterilization beyond the manufacturer-provided packaging is required. It is designed for use in controlled microbiology laboratory settings, where standard immunoassay protocols apply.

• Is the CMV RQ Bio-Enzabead Kit sterile or reusable?

  The kit is not intended for reuse and is supplied in sterile packaging as a single-use diagnostic reagent. Sterility is maintained by the manufacturer, and no further sterilization steps are necessary before use.

• What regulatory pathway does the CMV RQ Bio-Enzabead Kit follow?

  The CMV RQ Bio-Enzabead Kit was granted FDA 510(k) clearance under the Traditional pathway in 1983 (K831343) with a Substantially Equivalent (SESE) determination. It is classified as a Class II medical device under FDA regulation 866.3175, specifically for enzyme-linked immunosorbent assays related to CMV detection.

• How should the CMV RQ Bio-Enzabead Kit be stored?

  Storage follows standard laboratory protocols for immunoassay reagents. The kit should be stored in a controlled environment, protected from extreme temperatures, moisture, and direct light, to maintain its integrity and performance. Always refer to the manufacturer’s instructions for precise storage guidelines.