Nano-CheckTM AMI cTnI CD7141

GUDID 00895160002076

In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human serum and plasma

NANO-DITECH CORPORATION

Troponin I IVD, kit, rapid ICT, clinical

• Primary Device ID: 00895160002076
• NIH Device Record Key: 1a9f3bc0-9ed4-4a0e-931d-7e2253521b57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nano-CheckTM AMI cTnI
• Version Model Number: CD7141
• Catalog Number: CD7141
• Company DUNS: 126544316
• Company Name: NANO-DITECH CORPORATION
• Device Count: 20
• 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: true
• 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: 609-409-3300
• Email: info@nanoditech.com
• Phone: 609-409-3300
• Email: info@nanoditech.com
• Phone: 609-409-3300
• Email: info@nanoditech.com
• Phone: 609-409-3300
• Email: info@nanoditech.com
• Phone: 609-409-3300
• Email: info@nanoditech.com
• Phone: 609-409-3300
• Email: info@nanoditech.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00895160002076 [Primary]
GS1	10895160002073 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102131

FDA Product Code

• MMI: Immunoassay Method, Troponin Subunit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-09-14

On-Brand Devices [Nano-CheckTM AMI cTnI ]

• 00895160002113: In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human whole blood, plasm
• 00895160002076: In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human serum and plasma