Cardiac Control Complete +TnT level 3

Basic Information

• Brand Name: Cardiac Control Complete +TnT level 3
• Primary DI: 00817238011629
• Version / Model: 91492
• Company Name: CLINIQA CORPORATION
• Labeler DUNS: 078742335
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-25
• Public Version: 1
• Public Version Date: 2019-02-25
• Public Version Status: New
• Public Device Record Key: 6da021b3-32d9-4a15-897c-24e174d86eb3

Device Description

Cardiac Control Complete +TnT level 3

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817238011629	GS1

Premarket Submissions

Submission Number	Supplement Number
K080973	000