Cytomegalovirus Control Slides

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

510(k) Number

K873114 ↗

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 are Cytomegalovirus Control Slides used for?

  Cytomegalovirus Control Slides are antigen control slides designed for the positive immunohistochemical staining of cytomegalovirus, including related viruses such as herpes simplex virus types 1 and 2, varicella zoster virus, and Epstein Barr virus.

• How are Cytomegalovirus Control Slides supplied?

  These slides are supplied as Class II medical devices regulated under 21 CFR 866.3175 with FDA 510(k) clearance K873114. They are manufactured by Medical Diagnostic Technologies, Inc. and intended for use in microbiology laboratories.

• What regulatory status do Cytomegalovirus Control Slides have?

  Cytomegalovirus Control Slides have FDA 510(k) clearance K873114 and are classified as Class II medical devices under 21 CFR 866.3175. They are manufactured by Medical Diagnostic Technologies, Inc. and are intended for immunohistochemical staining procedures in microbiology laboratories.

• What viruses can be detected using Cytomegalovirus Control Slides?

  These slides are designed for the positive immunohistochemical staining of cytomegalovirus, as well as related viruses including herpes simplex virus types 1 and 2, varicella zoster virus, and Epstein Barr virus.