AccessGUDID - DEVICE: Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test (B103A25CS30021)

GUDID

Device Identifier (DI) Information

Brand Name: Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test
Version or Model: CS3002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CS3002
Company Name: International Point of Care Incorporated

Primary DI Number: B103A25CS30021
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 243942278 *Terms of Use

Device Description: Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB 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?
61295	Multiple cardiac marker 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 multiple combinations of cardiac markers [e.g., B-type natriuretic protein, D-dimer, creatine kinase myocardial isoenzyme (CKMB), myoglobin, myeloperoxidase (MPO), fatty acid binding protein (FABP), glycogen phosphorylase isoenzyme BB (GPBB), troponin I, troponin T] 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
DEA	Myoglobin, Fitc, Antigen, Antiserum, Control
MMI	Immunoassay Method, Troponin Subunit
JHT	Chromatographic Separation, Cpk Isoenzymes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020950	000
K022409	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: f67d07bc-dfd4-46cf-8165-19509b9e8123
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: September 15, 2016