NA

Basic Information

• Brand Name: NA
• Primary DI: 00816576020232
• Version / Model: J212
• Catalog Number: J212
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 4
• Public Version Date: 2021-10-26
• Public Version Status: Update
• Public Device Record Key: 91fcb020-eb37-4cde-a505-db95d3182724
• Distribution End Date: 2021-10-25

Device Description

CLED (Cystine Lactose Electrolyte Deficient): For the isolation, enumeration, and presumptive identification of urinary pathogens. Mueller Hinton: For antimicrobial susceptibility testing of non-fastidious bacteria.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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: No

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
58585	Differential/selective agar culture medium IVD	An agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816576020232	GS1
Unit of Use	00816576021314	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K811646	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius