Triage

Basic Information

• Brand Name: Triage
• Primary DI: 30014613337072
• Version / Model: 98814EU
• Catalog Number: 98814EU
• Company Name: QUIDEL CARDIOVASCULAR INC.
• Labeler DUNS: 080890141
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-07
• Public Version: 2
• Public Version Date: 2023-06-16
• Public Version Status: Update
• Public Device Record Key: f3766de3-6ca1-4fbf-a75a-a281c089e745

Device Description

Triage PLGF Control 2

Device Characteristics

• Single Use: Yes
• 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: 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
JJX	Single (specified) analyte controls (assayed and unassayed)	Clinical Chemistry	862.1660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56619	Placental growth factor (PLGF) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of placental growth factor (PLGF) 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	30014613337072	GS1

Customer Contacts

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