NA

Basic Information

• Brand Name: NA
• Primary DI: 00816576020218
• Version / Model: J101
• Catalog Number: J101
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-02
• Public Version: 3
• Public Version Date: 2020-06-18
• Public Version Status: Update
• Public Device Record Key: 10e4525e-851f-406c-b101-bc415a153e5c
• Distribution End Date: 2020-06-17

Device Description

CHOCOLATE with BAC / MTM BIPLT (Section I: Chocolate with Bacitracin; Section II: Modified Thayer Martin). For the selective isolation of 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
JTY	Culture Media, For Isolation Of Pathogenic Neisseria	Microbiology	866.2410	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58610	Haemophillus species agar identification medium IVD	A selective and/or differential agar culture medium intended to be used for the identification of Haemophilus species in a clinical specimen using supplementary X, V and XV factors supplied by disc diffusion.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816576020218	GS1
Unit of Use	00816576021277	GS1

Customer Contacts

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

Storage Conditions

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