Triage

Basic Information

• Brand Name: Triage
• Primary DI: 30014613338109
• Version / Model: 94600
• Catalog Number: 94600
• Company Name: QUIDEL CARDIOVASCULAR INC.
• Labeler DUNS: 080890141
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-02
• Public Version: 1
• Public Version Date: 2019-08-12
• Public Version Status: New
• Public Device Record Key: 1809dde7-ae1f-467d-bff7-5a0a5e73b269

Device Description

Triage TOX Drug Screen, 94600

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
LAF	Gas chromatography, methamphetamine	Clinical Toxicology	862.3610	2
KHO	FLUOROMETER, FOR CLINICAL USE	Clinical Chemistry	862.2560	1
DIS	Enzyme immunoassay, barbiturate	Clinical Toxicology	862.3150	2
JXM	Enzyme immunoassay, benzodiazepine	Clinical Toxicology	862.3170	2
LFG	Radioimmunoassay, tricyclic antidepressant drugs	Clinical Toxicology	862.3910	2
LDJ	Enzyme immunoassay, cannabinoids	Clinical Toxicology	862.3870	2
JXO	Enzyme immunoassay, cocaine	Clinical Toxicology	862.3250	2
DJR	Enzyme immunoassay, methadone	Clinical Toxicology	862.3620	2
DJG	Enzyme immunoassay, opiates	Clinical Toxicology	862.3650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55459	Multiple drugs of abuse 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 multiple drugs of abuse in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30014613338109	GS1

Customer Contacts

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