Cardiac STATus Controls (CK-MB/MYOGLOBIN/TROPONIN I) CSC3023

GUDID B103CSC30231

Cardiac STATus Controls (CK-MB/Myoglobin/Troponin I) are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of Cardiac STATus tests.

International Point of Care Incorporated

Multiple cardiac marker IVD, control

• Primary Device ID: B103CSC30231
• NIH Device Record Key: 92721a59-66c9-4c7a-8ac4-1df6ef051767
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardiac STATus Controls (CK-MB/MYOGLOBIN/TROPONIN I)
• Version Model Number: CSC3023
• Catalog Number: CSC3023
• Company DUNS: 243942278
• Company Name: International Point of Care Incorporated
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B103CSC30230 [Unit of Use]
HIBCC	B103CSC30231 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981474

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07

Devices Manufactured by International Point of Care Incorporated

• B103CSC30231 - Cardiac STATus Controls (CK-MB/MYOGLOBIN/TROPONIN I): 2022-12-15Cardiac STATus Controls (CK-MB/Myoglobin/Troponin I) are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of Cardiac STATus tests.
• B103CSC30231 - Cardiac STATus Controls (CK-MB/MYOGLOBIN/TROPONIN I): 2022-12-15 Cardiac STATus Controls (CK-MB/Myoglobin/Troponin I) are intended for use as assayed quality control materials in quality assura
• B103A10CS10021 - Cardiac STATus® TnI: 2018-07-06 Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum.
• B103A10CS30021 - Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem T: 2018-07-06 Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood,
• B103A20CS10021 - Cardiac STATus® TnI: 2018-07-06 Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum.
• B103A20CS30021 - Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem T: 2018-07-06 Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood,
• B103A25CS10021 - Cardiac STATus® TnI: 2018-07-06 Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum.
• B103A25CS30021 - Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem T: 2018-07-06 Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood,