Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem T CS3002

GUDID B103A10CS30021

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

International Point of Care Incorporated

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Primary Device ID	B103A10CS30021
NIH Device Record Key	ad67c049-53d9-4709-b1ce-fda64f5a0cef
Commercial Distribution Status	In Commercial Distribution
Brand Name	Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem T
Version Model Number	CS3002
Catalog Number	CS3002
Company DUNS	243942278
Company Name	International Point of Care Incorporated
Device Count	10
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	B103A10CS30021 [Primary]
HIBCC	B103CS30020 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K020950

FDA Product Code

JHT	Chromatographic Separation, Cpk Isoenzymes

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 Myoglobin/Troponin I/CK-MB Tandem T]

B103A25CS30021	Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB i
B103A20CS30021	Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB i
B103A10CS30021	Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB i