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

GUDID B103A25CS30021

Multiple cardiac marker IVD, kit, immunochromatographic test (ICT), rapid

Primary Device ID	B103A25CS30021
NIH Device Record Key	f67d07bc-dfd4-46cf-8165-19509b9e8123
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	25
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

Device Issuing Agency	Device ID
HIBCC	B103A25CS30021 [Primary]
HIBCC	B103CS30020 [Unit of Use]

DEA	Myoglobin, Fitc, Antigen, Antiserum, Control

Steralize Prior To Use	false
Device Is Sterile	false

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