CAPTIA CMV-G

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

Full name

Captia(R) Cmv-G

510(k) Number

K896194 ↗

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

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  FDA 510(k) K881425 Active Cleared 4 Aug 1988

• Modified Captia(R) Syphilis-M

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  FDA 510(k) K900654 Active Cleared 8 Mar 1990

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

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  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-G ELISA used for?

  The CAPTIA CMV-G ELISA is an in vitro diagnostic device designed to quantify immunoglobulin G (IgG) antibodies to cytomegalovirus (CMV). It aids in the serological diagnosis of CMV infection or immunity by providing quantitative results, helping clinicians assess a patient’s exposure or disease status related to CMV.

• How is the CAPTIA CMV-G ELISA supplied and stored?

  The CAPTIA CMV-G ELISA is supplied as a single-use reagent kit intended for professional laboratory use. It requires standard refrigeration for storage, with no additional specialized conditions needed. Always follow standard laboratory practices to maintain sterility and accuracy.

• Is the CAPTIA CMV-G ELISA intended for single-use or reuse?

  The CAPTIA CMV-G ELISA is explicitly designed for single-use only. This ensures sterility, consistency, and reliability in diagnostic results, as reuse could compromise the integrity of the assay and introduce contamination risks.

• What are the key specifications or regulatory details for this device?

  The CAPTIA CMV-G ELISA has been granted FDA 510(k) clearance under product code LFZ, adhering to 21 CFR 866.3175. It is classified as an Enzyme Linked Immunoabsorbent Assay (ELISA) and falls under the microbiological assays category for clinical microbiology use. The device is not MRI-compatible and must be handled according to standard immunoassay laboratory protocols.

• Can this device be used outside of a clinical microbiology lab?

  No, the CAPTIA CMV-G ELISA is specifically designed for laboratory use in clinical microbiology settings. Its intended use relies on controlled conditions, trained personnel, and proper equipment to ensure accurate and reliable diagnostic results for CMV antibody quantification.