TriniCHECK™ Lupus Positive Control

GUDID 15391521420661

TCOAG IRELAND LIMITED

Lupus anticoagulant marker IVD, kit, clotting Lupus anticoagulant marker IVD, kit, clotting

• Primary Device ID: 15391521420661
• NIH Device Record Key: 64e491d6-eeaa-497c-b4c6-c2ba2ea3cea0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriniCHECK™ Lupus Positive Control
• Version Model Number: T4203
• Company DUNS: 985039126
• Company Name: TCOAG IRELAND LIMITED
• Device Count: 6
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391521420664 [Unit of Use]
GS1	15391521420661 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961370

FDA Product Code

• GGC: Control, Plasma, Abnormal

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: 2016-09-12

Devices Manufactured by TCOAG IRELAND LIMITED

• 15391521421286 - TriniLIZE™ Stabilyte tubes: 2019-07-19
• 15391521420470 - TriniCLOT Lupus Screen: 2019-07-08
• 15391521420487 - TriniCLOT Lupus Confirm: 2019-07-08
• 15391521420630 - TriniCHECK Level 1: 2019-07-08
• 15391521420647 - TriniCHECK Level 2: 2019-07-08
• 15391521420654 - TriniCHECK Level 3: 2019-07-08
• 15391521421309 - DT Wash: 2019-07-08
• 15391521421729 - DT Fluid: 2019-07-08