Cardiac STATus® TnI CS1002

GUDID B103A20CS10021

Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum.

International Point of Care Incorporated

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• Primary Device ID: B103A20CS10021
• NIH Device Record Key: d3d8e8c3-0b82-4c1f-9f44-ae766a7c96f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardiac STATus® TnI
• Version Model Number: CS1002
• Catalog Number: CS1002
• Company DUNS: 243942278
• Company Name: International Point of Care Incorporated
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 416-847-2777
• Email: customerservice@ipocdx.com
• Phone: 416-847-2777
• Email: customerservice@ipocdx.com
• Phone: 416-847-2777
• Email: customerservice@ipocdx.com
• Phone: 416-847-2777
• Email: customerservice@ipocdx.com
• Phone: 416-847-2777
• Email: customerservice@ipocdx.com
• Phone: 416-847-2777
• Email: customerservice@ipocdx.com
• Phone: 416-847-2777
• Email: customerservice@ipocdx.com
• Phone: 416-847-2777
• Email: customerservice@ipocdx.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B103A20CS10021 [Primary]
HIBCC	B103CS10020 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014105

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Cardiac STATus® TnI]

• B103A25CS10021: Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Wh
• B103A20CS10021: Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Wh
• B103A10CS10021: Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Wh