NA

Basic Information

• Brand Name: NA
• Primary DI: 00816576028948
• Version / Model: E130BX
• Catalog Number: E130BX
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-03-31
• Public Version: 1
• Public Version Date: 2020-04-08
• Public Version Status: New
• Public Device Record Key: aa13ac02-4afd-4d55-bb2b-a17ae015ef5a

Device Description

THAYER MARTIN, MODIFIED Hardy Diagnostics Modified Thayer Martin (MTM) is a selective medium used in qualitative procedures for the isolation of Neisseria gonorrhoeae with suppression of most other gram-negative diplococci, gram-negative bacilli, gram-positive organisms, and yeast.

Device Characteristics

• Single Use: Yes
• 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: 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
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
Unit of Use	00816576020072	GS1
Primary	00816576028948	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K934331	000

Storage Conditions

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