AccessGUDID - DEVICE: Triage (30014613337867)

GUDID

Device Identifier (DI) Information

Brand Name: Triage
Version or Model: 94400
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 94400
Company Name: QUIDEL CARDIOVASCULAR INC.

Primary DI Number: 30014613337867
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 080890141 *Terms of Use

Device Description: Triage TOX Drug Screen

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDP	COLORIMETRY, ACETAMINOPHEN
MLK	Thin layer chroomatography, tricyclic antidepressant drugs
DKZ	Enzyme immunoassay, amphetamine
LAF	Gas chromatography, methamphetamine
JXM	Enzyme immunoassay, benzodiazepine
LCM	Enzyme immunoassay, phencyclidine
LDJ	Enzyme immunoassay, cannabinoids
DIS	Enzyme immunoassay, barbiturate
JXO	Enzyme immunoassay, cocaine
DJR	Enzyme immunoassay, methadone
DJG	Enzyme immunoassay, opiates

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cac12546-f410-4193-b03f-34e490d2417e
Public Version Date: June 26, 2025
Public Version Number: 3
DI Record Publish Date: November 01, 2018