CAPTIA CMV-M

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

Full name

Captia(R) Cmv-M

510(k) Number

K896295 ↗

FDA Product Code

LFZ

FDA applicant

Mercia Diagnostics , Ltd.

Device Class

Class II

Regulation

21 CFR Part 866.3175

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Captia(R) Rubella-G

  Class II

  FDA 510(k) K883924 Active Cleared 15 Aug 1989

• Captia(R) Syphilis-G

  Class II

  FDA 510(k) K881425 Active Cleared 4 Aug 1988

• Modified Captia(R) Syphilis-M

  Class II

  FDA 510(k) K900654 Active Cleared 8 Mar 1990

• Captia(R) Toxo-M: an Enzyme Immunoassay

  Class II

  FDA 510(k) K871746 Active Cleared 31 Jul 1987

• Rotascreen

  Class I

  FDA 510(k) K872568 Active Cleared 14 Sep 1987

• Captia Toxo-G

  Class II

  FDA 510(k) K880918 Active Cleared 1 Aug 1988

See all devices from Mercia Diagnostics, Ltd. →

• What is the CAPTIA CMV-M used for in a clinical setting?

  The CAPTIA CMV-M is an ELISA test designed to detect cytomegalovirus (CMV) IgM antibodies in human serum or plasma. It helps identify recent or acute CMV infection by detecting IgM antibodies, which indicate primary exposure to the virus. This aids clinicians in diagnosing active CMV infections in patients.

• Is the CAPTIA CMV-M kit meant for single-use or can it be reused?

  The CAPTIA CMV-M is explicitly supplied as a single-use diagnostic kit. Each kit is intended for one test procedure only, ensuring accuracy and preventing cross-contamination in clinical microbiology laboratories.

• What storage conditions are required for the CAPTIA CMV-M?

  The CAPTIA CMV-M does not require any special storage conditions beyond standard refrigeration. This makes it convenient for clinical laboratories to store and maintain without additional infrastructure.

• How is the CAPTIA CMV-M regulated in the U.S.?

  The CAPTIA CMV-M has received FDA 510(k) clearance (K896295) under the Microbiology advisory committee, classified as a Class II device (regulation number 866.3175). This means it has been determined to be substantially equivalent to a predicate device and is authorized for professional laboratory use only.

• Can the CAPTIA CMV-M be used outside of a clinical microbiology lab?

  No, the CAPTIA CMV-M is explicitly intended for use in clinical microbiology laboratories. Its design and regulatory clearance reflect its purpose as a professional diagnostic tool, not for point-of-care or home testing.