PRIME SCREEN®

GUDID 00810174471045

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

WONDFO USA CO., LTD.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

• Primary Device ID: 00810174471045
• NIH Device Record Key: 2abd4f1b-02ae-481f-bf63-2c1c07da402a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIME SCREEN®
• Version Model Number: DCDOA-254-1BX-A
• Company DUNS: 849098897
• Company Name: WONDFO USA CO., LTD.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810174471038 [Unit of Use]
GS1	00810174471045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182701

FDA Product Code

• NFT: Test, Amphetamine, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-11
• Device Publish Date: 2025-12-03

On-Brand Devices [PRIME SCREEN®]

• 00810174471151: 10-Panel T-Square with indicator; 25 per box; AMP,BAR,COC,MDMA,MET,MTD,OPI,OXY,PCP,THC
• 00810174471137: 6-Panel T-Swab; AMP-COC- OPI;MET-THC-PCP
• 00810174471045: Prime Screen®; 5- Panel T-Cup Compact; AMP,COC,mAMP,OPI,THC
• 00810174470949: Prime Screen® 12-Panel T-Cup Compact; 2 per Box; AMP,BAR,BUP,BZO,COC,MDMA,MTD,OPI,OXY,PCP,TCA,T