BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Cardiac STATus® TnI

DI: B103A20CS10021 · Model: CS1002 · International Point of Care Incorporated

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

20

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Basic Information

Brand Name: Cardiac STATus® TnI
Primary DI: B103A20CS10021
Version / Model: CS1002
Catalog Number: CS1002
Company Name: International Point of Care Incorporated
Labeler DUNS: 243942278
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 20
Record Status: Published
Publish Date: 2016-09-15
Public Version: 5
Public Version Date: 2025-02-07
Public Version Status: Update
Public Device Record Key: d3d8e8c3-0b82-4c1f-9f44-ae766a7c96f3
Distribution End Date: 2024-04-01

Device Description

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

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	862.1215	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46989	Troponin I IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of troponin I in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B103A20CS10021	HIBCC
Unit of Use	B103CS10020	HIBCC

Customer Contacts

Phone: 416-847-2777
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K014105	000