Blastomyces Dermatitidis Pos/Control (K792681)

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

Full name

Blastomyces Dermatitidis Pos/Control

510(k) Number

K792681 ↗

FDA Product Code

KFH

Device Class

Class II

Regulation

21 CFR Part 866.3060

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 Blastomyces Dermatitidis Pos/Control used for?

  This device serves as a reference standard for microbiological testing, providing a confirmed positive sample of *Blastomyces dermatitidis* antigens. It validates diagnostic assays and ensures test accuracy in clinical microbiology labs, helping confirm the presence of the organism in patient samples.

• How is the Blastomyces Dermatitidis Pos/Control supplied and intended for use?

  The control is supplied as a reagent for in vitro use in microbiology laboratories. It is designed for single-use applications only, eliminating the need for additional sterilization beyond the manufacturer-provided packaging. This ensures consistency and reliability for each test run.

• Is the Blastomyces Dermatitidis Pos/Control sterile and reusable?

  The control is not intended for reuse and is supplied in sterile packaging as part of its single-use design. No further sterilization is required beyond what the manufacturer provides, ensuring safety and integrity for each use.

• What regulatory approval does the Blastomyces Dermatitidis Pos/Control hold?

  This device holds FDA 510(k) clearance (K792681) and is classified under FDA regulation 866.3060 as an Antiserum, Positive Control. It is designated as Class II with special controls, reviewed by the Microbiology (MI) advisory committee, ensuring compliance with stringent microbiological standards.

• Where can I find storage instructions and shelf life details for the Blastomyces Dermatitidis Pos/Control?

  Storage conditions and shelf life information are provided in the accompanying manufacturer documentation. Always refer to the packaging or included instructions for precise guidelines to maintain product efficacy and integrity before use.