Mueller Hinton Medium W/Sheep Blood

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

510(k) Number

K791818 ↗

FDA Product Code

JTZ

Device Class

Class II

Regulation

21 CFR Part 866.1700

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Brain Heart Infusion Agar

  Class I

  FDA 510(k) K791630 Active Cleared 27 Sep 1979

• Kf Streptococcus Agar

  Class I

  FDA 510(k) K792287 Active Cleared 19 Dec 1979

• Mannitol Salt Agar

  Class I

  FDA 510(k) K791627 Active Cleared 27 Sep 1979

• Mueller Hinton Agars

  Class II

  FDA 510(k) K791485 Active Cleared 22 Aug 1979

• Tryptic Soy Broth

  Class I

  FDA 510(k) K791171 Active Cleared 17 Jul 1979

• Motility Gi Medium

  Class I

  FDA 510(k) K812798 Active Cleared 20 Oct 1981

See all devices from Isle Media and Sterile Products, Inc. →

• What is the primary use of Mueller Hinton Medium with Sheep Blood?

  Mueller Hinton Medium with Sheep Blood is a solid culture medium designed for qualitative antimicrobial susceptibility testing. It is specifically formulated for use with the standardized Kirby-Bauer disk diffusion method.

• What are the key components of this culture medium?

  The medium is composed of Mueller Hinton agar base supplemented with 5% defibrinated sheep blood, beef infusion, casamino acids, and starch to support the growth requirements of fastidious organisms during susceptibility testing.

• What is the regulatory status of this culture medium?

  This device is authorized under FDA 510K clearance, specifically identified by K-number K791818, and is classified as a Class 2 medical device for microbiology applications.