Triage

Basic Information

• Brand Name: Triage
• Primary DI: 30014613337133
• Version / Model: 94413
• Catalog Number: 94413
• Company Name: QUIDEL CARDIOVASCULAR INC.
• Labeler DUNS: 080890141
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-01
• Public Version: 3
• Public Version Date: 2023-03-09
• Public Version Status: Update
• Public Device Record Key: 24bca5f8-d4aa-4637-9a96-70225f2be8d5
• Distribution End Date: 2023-02-28

Device Description

Quidel Triage TOX Drug Screen Control 1

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
DIF	Drug mixture control materials	Clinical Toxicology	862.3280	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30503	Multiple therapeutic drugs/drugs of abuse 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 multiple therapeutic drugs and drugs of abuse in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30014613337133	GS1

Customer Contacts

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