Cryptococcus Neoformans Antiserum, Latex

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

510(k) Number

K792693 ↗

FDA Product Code

GMD

Device Class

Class II

Regulation

21 CFR Part 866.3165

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Blastomyces Dermatitidis Antigen (JWW)

  Class II

  FDA 510(k) K792680 Active Cleared 17 Jan 1980

• Candida Albicans, Antiserum

  Class II

  FDA 510(k) K792713 Active Cleared 23 Jan 1980

• Lacto-Phenol Analine Blue Fluid

  Class I

  FDA 510(k) K792703 Active Cleared 24 Jan 1980

• Immunocard Mycoplasma

  Class I

  FDA 510(k) K934550 Active Cleared 20 Sep 1994

• Histoplasma Capsulatum, Antiserum

  Class II

  FDA 510(k) K792718 Active Cleared 17 Jan 1980

• Blastomyces Dermatitidis, Antiserum

  Class II

  FDA 510(k) K792685 Active Cleared 17 Jan 1980

See all devices from Meridian Diagnostics, Inc. →

• What is the Cryptococcus Neoformans Antiserum Latex used for?

  The Cryptococcus Neoformans Antiserum Latex is a diagnostic device used for the detection of Cryptococcus Neoformans antigens through latex agglutination. It aids in the identification of this pathogenic fungus that can cause serious infections.

• How is the Cryptococcus Neoformans Antiserum Latex supplied?

  The device is supplied as a latex agglutination test for microbiology laboratory use. It is manufactured by Meridian Diagnostics, Inc. with model number K792693.

• What is the regulatory classification of this device?

  The Cryptococcus Neoformans Antiserum Latex is regulated under FDA 510(k) clearance with product code GMD. It is classified as Class II with Special Controls for microbiology laboratory use.

• Is the device sterile and can it be reused?

  The provided data does not include information regarding sterility, single-use or reusable status of the Cryptococcus Neoformans Antiserum Latex device.