E450

GUDID 00816576020089

THAYER MARTIN, MODIFIED For the selective isolation of N. gonorrheoeae with suppression of most other gram-negative diplococci, gram-negative bacilli, gram-positive organisms, and yeast. Plate has a "pill pocket" receptacle for the addition of a CO2 tablet. Includes 10 CO2 tablets and 10 ziplock bags.

HARDY DIAGNOSTICS

Differential/selective agar culture medium IVD Differential/selective agar culture medium IVD Differential/selective agar culture medium IVD

• Primary Device ID: 00816576020089
• NIH Device Record Key: 96df594c-211e-4ece-8e3f-23a9ec232d6e
• Commercial Distribution Discontinuation: 2016-09-02
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: E450
• Catalog Number: E450
• Company DUNS: 039981550
• Company Name: HARDY DIAGNOSTICS
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816576020089 [Primary]
GS1	00816576021383 [Unit of Use]

FDA Product Code

• JTY: Culture Media, For Isolation Of Pathogenic Neisseria

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-31
• Device Publish Date: 2016-09-02

Devices Manufactured by HARDY DIAGNOSTICS

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• 00816576026876 - N/A: 2024-03-18 C. auris Enrichment Broth, Fill 2mL (Sabouraud Salt Dulcitol Broth with Chloramphenicol & Gentamicin) For the selective enrichme
• 00819398021593 - N/A: 2024-01-23 BHI Broth, 4mL, 100 tubes/pack (Brain Heart Infusion Broth) For the cultivation of fastidious and nonfastidious microorganisms.
• 00819398020602 - N/A: 2024-01-09 Modified Diamonds Medium, 16x100mm Tube, 6ml. Hardy Diagnostics Modified Diamonds Medium is recommended as an enriched and sele
• 00816576026838 - HardyCHROM™: 2023-12-18 HardyCHROM™ CRE/ HardyCHROM™ ESBL, 15x100mm Biplate, 10ml/10ml. HardyCHROM™ CRE is a selective and differential chromogen
• 00816576024391 - AnaeroGRO: 2023-12-06 Bacteroides Bile Esculin Agar, Monoplate. Hardy Diagnostics AnaeroGRO™ Bacteroides Bile Esculin Agar is an enriched, selectiv
• 00819398020725 - HardyDisk™: 2023-11-29 Sulbactam / Durlobactam 10 /10 µg (SUD20), 5 x 50 disks, used for semi-quantitative in vitro susceptibility testing by the agar
• 00819398023627 - N/A: 2023-11-28 PPLO Broth, for Mycoplasma pneumoniae, 5ml, 13x100mm tube, order by the package of 20 For the cultivation and maintenance of myc