Triage

Basic Information

• Brand Name: Triage
• Primary DI: 30014613337928
• Version / Model: 97000HSEU
• Catalog Number: 97000HSEU
• Company Name: QUIDEL CARDIOVASCULAR INC.
• Labeler DUNS: 080890141
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-01
• Public Version: 2
• Public Version Date: 2020-04-03
• Public Version Status: Update
• Public Device Record Key: d6c9a5fd-93fc-4a56-a978-957f1df54e8b

Device Description

Triage Cardiac Panel (OUS)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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
DOR	RADIOIMMUNOASSAY, DIGOXIN (3-H), BOVINE ANTIBODY, CHARCOAL SEP.	Clinical Toxicology	862.3320	2
MMI	IMMUNOASSAY METHOD, TROPONIN SUBUNIT	Clinical Chemistry	862.1215	2
JHX	FLUOROMETRIC METHOD, CPK OR ISOENZYMES	Clinical Chemistry	862.1215	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47384	Multiple cardiac marker IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen, using a fluorescent immunoassay method. Cardiac markers to be assayed 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	30014613337928	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]