U-Catch Marijuana Multi-Level Drug Test Card(Colloidal Gold)

Basic Information

• Brand Name: U-Catch Marijuana Multi-Level Drug Test Card(Colloidal Gold)
• Primary DI: 06977469280080
• Version / Model: ETG021010
• Company Name: Eterbio, Inc.
• Labeler DUNS: 638595825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-18
• Public Version: 1
• Public Version Date: 2024-12-26
• Public Version Status: New
• Public Device Record Key: ef852f69-438a-43ba-b3aa-fe3b782f6fac

Device Description

10 Tests/Kit

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: Yes
• 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
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30519	Cannabinoid/cannabinoid metabolite 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 cannabinoids and/or cannabinoid metabolites (i.e., natural, synthetic) 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
Primary	06977469280080	GS1