u-Card Drug Test Screen

Basic Information

• Brand Name: u-Card Drug Test Screen
• Primary DI: 10817038022112
• Version / Model: U-MET-114L
• Catalog Number: U-MET-114L
• Company Name: UCP BIOSCIENCES, INC.
• Labeler DUNS: 163610020
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2022-06-16
• Public Version: 2
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: ca9b2294-2a3c-4007-89b6-0b5897516dba
• Distribution End Date: 2032-06-15

Device Description

MET Single Panel Dip Test Card

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No
• 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
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	862.3610	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55489	Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs belonging to the amphetamine and/or methamphetamine group(s) [e.g., 3,4-methylenedioxymethamphetamine (MDMA), also known as ecstasy] in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20817038022119	GS1	case	40	In Commercial Distribution	2032-06-14
Primary	10817038022112	GS1
Unit of Use	00817038022115	GS1

Premarket Submissions

Submission Number	Supplement Number
K131811	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius