NA

Basic Information

• Brand Name: NA
• Primary DI: 00816576020195
• Version / Model: J44
• Catalog Number: J44
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-02
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8136c154-938c-4039-b336-5ad5d4ddbc49

Device Description

CHOC. / M.L. with LINCO. BIPLATE (Chocolate Agar / Martin Lewis with Lincomycin). A biplate for the cultivation and isolation of Neisseria gonorrhoeae.

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: 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: 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
58678	Thayer-Martin Neisseria species agar culture medium IVD	A selective and/or differential agar culture medium that uses the Thayer-Martin formulation, or modified formulation, and is intended to be used for the growth and isolation of Neisseria gonorrhoea and other Neisseria species from a clinical specimen.	No	Obsolete
58540	Basic chocolate agar culture medium IVD	A non-selective agar culture medium containing heat-lysed red blood cells intended to be used for the growth and isolation of fastidious bacteria from a clinical specimen.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816576020195	GS1
Unit of Use	00816576021338	GS1

Customer Contacts

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

Storage Conditions

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