AccessGUDID - DEVICE: Cardiac STATus® TnI (B103A20CS10021)

GUDID

Device Identifier (DI) Information

Brand Name: Cardiac STATus® TnI
Version or Model: CS1002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CS1002
Company Name: International Point of Care Incorporated

Primary DI Number: B103A20CS10021
Issuing Agency: HIBCC
Commercial Distribution End Date: April 01, 2024
Device Count: 20
Labeler D-U-N-S® Number*: 243942278 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMI	Immunoassay Method, Troponin Subunit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K014105	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d3d8e8c3-0b82-4c1f-9f44-ae766a7c96f3
Public Version Date: February 07, 2025
Public Version Number: 5
DI Record Publish Date: September 15, 2016