Remel Bile Esculin Azide Agar W/6 Mcg/Ml Vancomycin

• • Terminated Z-1561-2021 FDA Class II ·initiated 22 Apr 2021

  The media allows growth of E. faecalis ATCC 29212 with blackening of the media.

510(k) Number

K972359 ↗

FDA Product Code

JSO

Device Class

Class II

Regulation

21 CFR Part 866.1700

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Remel, L.P. →

• What is Remel Bile Esculin Azide Agar with 6 mcg/mL Vancomycin used for?

  This medium is designed to isolate and presumptively identify vancomycin-resistant enterococci (VRE) from clinical samples. It uses sodium azide and oxgall to suppress Gram-negative bacteria while vancomycin selectively targets resistant enterococcal strains. Esculin hydrolysis further differentiates group D streptococci, including enterococci, from other organisms.

• How is Remel Bile Esculin Azide Agar with Vancomycin supplied and prepared?

  The product is supplied as a dehydrated powder for laboratory preparation. It is not sterile upon receipt and must be reconstituted with sterile distilled water or another appropriate medium before use. It is intended for single-use in clinical microbiology settings.

• Is this medium sterile when received, and what are the storage instructions?

  No, the medium is not sterile upon receipt. It requires reconstitution with sterile water or an appropriate medium before use. Storage should follow manufacturer guidelines, typically in a cool, dry place protected from light until use.

• Can this medium be reused after preparation?

  No, Remel Bile Esculin Azide Agar with Vancomycin is intended for single-use only. Each preparation should be discarded after use to maintain accuracy and prevent contamination.

• What regulatory pathway does this product follow?

  This product is regulated under FDA 510(k) clearance with the clearance number K972359. It falls under device class II (866.1700) and is classified as an antimicrobial susceptibility test medium, excluding Mueller Hinton Agar.