Enzygnost Anti-CMV/IGM

No FDA recalls on record, checked 5 Oct 2026.

Full name

Enzygnost(R) Anti-Cmv/Igm

510(k) Number

K913693 ↗

FDA Product Code

LFZ

Device Class

Class II

Regulation

21 CFR Part 866.3175

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Behring Diagnostics, Inc. →

• What is the Enzygnost Anti-CMV/IGM used for?

  This device is an enzyme-linked immunoabsorbent assay (ELISA) designed to qualitatively detect IgM antibodies specific to cytomegalovirus (CMV). It helps clinicians identify acute or primary CMV infections by analyzing human serum or plasma samples, supporting diagnostic assessments in microbiology settings.

• How is the Enzygnost Anti-CMV/IGM supplied and intended for use?

  The kit is supplied as a single-use in vitro diagnostic reagent, requiring laboratory processing. It is intended exclusively for use in clinical microbiology laboratories to assist in diagnosing CMV infections through IgM antibody detection.

• Is the Enzygnost Anti-CMV/IGM sterile and single-use?

  Yes, the device is supplied as a single-use reagent kit. While the exact sterility claims are not detailed, its design as a diagnostic reagent implies it is intended for one-time use per sample to prevent cross-contamination and ensure accurate results.

• What storage instructions apply to the Enzygnost Anti-CMV/IGM?

  The kit must be stored according to the manufacturer’s instructions to preserve its integrity until use. Proper storage conditions are critical to maintaining the assay’s performance, as exposure to improper temperatures or light could compromise the reagents.

• Can this device be used for MRI or other imaging purposes?

  No, the Enzygnost Anti-CMV/IGM is explicitly not intended for MRI use. It is solely designed for laboratory-based diagnostic testing of serum or plasma samples to detect CMV IgM antibodies.