E31

GUDID 00816576020058

MARTIN LEWIS w/ LINCOMYCIN, PP (Martin Lewis Agar with lincomycin, reduced vancomycin, colistin, amphotericin, and trimethoprim) For the selective isolation of Neisseria gonorrhoeae. Petri plate has a "pill pocket" receptacle for the addition of a CO2 tablet. 10 tablets and 10 ziplock.

HARDY DIAGNOSTICS

Thayer-Martin Neisseria species agar culture medium IVD

• Primary Device ID: 00816576020058
• NIH Device Record Key: ec9df328-2e78-4a34-8020-3b040a958245
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: E31
• Catalog Number: E31
• Company DUNS: 039981550
• Company Name: HARDY DIAGNOSTICS
• Device Count: 10
• DM Exempt: true
• 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	00816576020058 [Primary]
GS1	00816576021208 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934331

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: 2018-07-06
• Device Publish Date: 2016-09-01

Devices Manufactured by HARDY DIAGNOSTICS

• 00816576027088 - HardyDisk™: 2025-08-18 HardyDisk™ AST Gepotidacin, 10ug (GEP10), 1x 50 disks For in vitro agar diffusion susceptibility testing when there is the nee
• 00816576026975 - HardyDisk™: 2025-07-22 HardyDisk™ AST Aztreonam-Avibactam 30 / 20ug (AZA50),5 x 50 disks For in vitro agar diffusion susceptibility testing when ther
• 00816576027439 - QwikID: 2025-07-01 QwikID H. pylori Rapid Antigen Test is a single use immunochromatographic assay for the qualitative detection of H. pylori antig
• 00819398027199 - N/A: 2025-03-18 Anaerobe Nitrate Reagent A, Sulfanilic Acid for nitrate reduction test, 15ml, formulated especially for anaerobic bacteria Hardy
• 00819398027779 - N/A: 2025-03-18 Anaerobe Nitrate Reagent B, Cleve's Acid for nitrate reduction test, formulated especially for anaerobic bacteria Hardy Diagnost
• 00816576023516 - N/A: 2025-02-19 DTM Agar (Dermatophyte Test Medium) A selective and differential medium for the detection and presumptive identification of derm
• 00816576025800 - TransPRO: 2024-10-16 TransPRO Viral Transport Medium System, single 16x100mm polypropylene tube, 3ml fill with individually wrapped, sterile, mini-ti
• 00816576026951 - N/A: 2024-07-16 G Vag Starch Agar, 15x100mm Monoplate. For the selective isolation and differentiation of Gardnerella vaginalis from other micro