AccessGUDID - DEVICE: Cardiac STATus Controls (CK-MB/MYOGLOBIN/TROPONIN I) (B103CSC30231)

GUDID

Device Identifier (DI) Information

Brand Name: Cardiac STATus Controls (CK-MB/MYOGLOBIN/TROPONIN I)
Version or Model: CSC3023
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CSC3023
Company Name: International Point of Care Incorporated

Primary DI Number: B103CSC30231
Issuing Agency: HIBCC
Commercial Distribution End Date: April 01, 2025
Device Count: 6
Labeler D-U-N-S® Number*: 243942278 *Terms of Use

Device Description: Cardiac STATus Controls (CK-MB/Myoglobin/Troponin I) are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of Cardiac STATus tests.

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:	No
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?
47016	Multiple cardiac marker IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen. The cardiac markers may include 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 and/or troponin T.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-Analyte Controls, All Kinds (Assayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K981474	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: 92721a59-66c9-4c7a-8ac4-1df6ef051767
Public Version Date: April 01, 2025
Public Version Number: 3
DI Record Publish Date: December 07, 2022