PRIME SCREEN®

Basic Information

• Brand Name: PRIME SCREEN®
• Primary DI: 00810174471045
• Version / Model: DCDOA-254-1BX-A
• Company Name: WONDFO USA CO., LTD.
• Labeler DUNS: 849098897
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2025-12-03
• Public Version: 1
• Public Version Date: 2025-12-11
• Public Version Status: New
• Public Device Record Key: 2abd4f1b-02ae-481f-bf63-2c1c07da402a

Device Description

Prime Screen®; 5- Panel T-Cup Compact; AMP,COC,mAMP,OPI,THC

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: 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
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	862.3100	2
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	862.3250	2
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	862.3610	2
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	862.3650	2
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	862.3870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46994	Multiple drugs of abuse 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 of abuse 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	00810174471045	GS1
Unit of Use	00810174471038	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K182701	000