PRIME SCREEN®

Basic Information

• Brand Name: PRIME SCREEN®
• Primary DI: 00810174471168
• Version / Model: DQODOA-10106EUO-I-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: ef074afc-28da-496a-be43-9a805505804d

Device Description

10-Panel T-Square with indicator; 25 per box; AMP,BAR,COC,MDMA,MET,MTD,OPI,OXY,PCP,THC

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: 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
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3100	2
PUY	Test, Barbiturate, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3150	2
PVA	Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3250	2
PVD	Test, Methamphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3610	2
PVE	Test, Methadone, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3620	2
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	862.3650	2
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	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
Unit of Use	00810174471151	GS1
Primary	00810174471168	GS1