TrinityBiotech 1206620

GUDID 05391516746342

Uni-Gold™ Cryptosporidium, 20 Tests

MARDX DIAGNOSTICS, INC.

Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot

• Primary Device ID: 05391516746342
• NIH Device Record Key: 57cd71b8-3ab6-443d-883b-46392eff871b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrinityBiotech
• Version Model Number: 1206620
• Catalog Number: 1206620
• Company DUNS: 154281349
• Company Name: MARDX DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-325-3424
• Email: info@trinitybiotech.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391516746342 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121565

FDA Product Code

• MHJ: Cryptosporidium Spp.

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: 2016-09-18

Devices Manufactured by MARDX DIAGNOSTICS, INC.

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• 05391516746212 - Trinity Biotech: 2018-07-06 B. burgdorferi (IgM) Marblot Strip Test System (20 Tests)
• 05391516746229 - Trinity Biotech: 2018-07-06 B. burgdorferi (IgG) Marblot Strip Test System (50 Tests)