Merifluor(Tm)-Giardia

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

510(k) Number

K873299 ↗

FDA Product Code

GWD

Device Class

Class II

Regulation

21 CFR Part 866.3220

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 types of samples can the Merifluor-Giardia test detect *Giardia lamblia* in, and how is the test performed?

  The Merifluor-Giardia test is designed to detect *Giardia lamblia* and related species in stool specimens only. It uses an indirect fluorescent antibody (IFA) method, where the sample is processed in a clinical microbiology lab. After preparation, the specimen is exposed to fluorescently labeled antibodies that bind to *Giardia* antigens. Under a fluorescence microscope, positive results appear as glowing parasites, allowing for rapid and sensitive identification of the infection.

• Is the Merifluor-Giardia kit meant for direct patient use, or does it require laboratory handling?

  The Merifluor-Giardia kit is not sterile and is not intended for direct patient administration. It is explicitly designed for use only in clinical microbiology laboratories, where trained personnel can perform the fluorescent microscopy required for accurate detection of *Giardia* antigens in processed stool samples.

• How is the Merifluor-Giardia kit supplied, and is it reusable?

  The Merifluor-Giardia kit is supplied as a single-use diagnostic kit, meaning each package is intended for one test procedure. This ensures consistency in results and prevents cross-contamination between samples. After use, the kit components should be discarded according to laboratory protocols for infectious waste.

• What regulatory pathway does the Merifluor-Giardia follow, and which advisory committee oversees its classification?

  The Merifluor-Giardia was cleared through the FDA’s 510(k) process (traditional pathway, clearance number K873299) and is classified as a Class II medical device under the FDA’s nomenclature. Its regulatory classification falls under microbiology, specifically for indirect fluorescent antibody tests, and was reviewed by the Microbiology (MI) Advisory Committee.