Cardiac STATus® TnI CS1002

GUDID B103A20CS10021

Troponin I IVD, kit, immunochromatographic test (ICT), rapid

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

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

MMI	Immunoassay Method, Troponin Subunit

Steralize Prior To Use	false
Device Is Sterile	false

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

Mark Image Registration \| Serial	Company Trademark Application Date
CARDIAC STATUS 76085100 2667759 Dead/Cancelled	NANOGEN, INC. 2000-07-07
CARDIAC STATUS 74635472 not registered Dead/Abandoned	SPECTRAL DIAGNOSTICS INC. 1995-02-17