Mueller Hinton Agar II

Basic Information

• Brand Name: Mueller Hinton Agar II
• Primary DI: 00860003684634
• Version / Model: 0
• Catalog Number: NCM0023E
• Company Name: NEOGEN CORPORATION
• Labeler DUNS: 069550929
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-20
• Public Version: 1
• Public Version Date: 2020-10-28
• Public Version Status: New
• Public Device Record Key: ddab67c2-f9a2-4489-bb3d-631900d8a81f

Device Description

(Conforms to CLSI) For use in antimicrobial susceptibility testing by the disk diffusion method.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JTZ	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth	Microbiology	866.1700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58639	Mueller-Hinton agar antimicrobial susceptibility culture medium IVD	A non-selective Mueller-Hinton agar culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on non-fastidious microorganisms in a clinical specimen and/or culture isolate.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003684634	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K811049	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius