PRIME SCREEN®

GUDID 00810174470994

Prime Screen® 6 panel T-swab, AMP,COC,OPI,MET,THC,PCP; 5 per box;

WONDFO USA CO., LTD.

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

• Primary Device ID: 00810174470994
• NIH Device Record Key: 90920967-9a5d-44cc-90cd-5f3fc4db9aa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIME SCREEN®
• Version Model Number: DSODOA-166EUO-5BX-A
• Company DUNS: 849098897
• Company Name: WONDFO USA CO., LTD.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810174470994 [Unit of Use]
GS1	00810174471007 [Primary]

FDA Product Code

• PUX: Test, Amphetamine, Employment And Insurance Testing, Exempt

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: 2025-12-15
• Device Publish Date: 2025-12-05

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
• 00810174471199: 5-Panel T-Swab; AMP, COC, MET, OPI, THC
• 00810174470994: Prime Screen® 6 panel T-swab, AMP,COC,OPI,MET,THC,PCP; 5 per box
• 00810174470970: 14-Panel T-Cup 10 per Box; AMP,BAR,BUP,BZO,CO C,MET,MDMA,MTD,OPI,OXY,PCP,PPX,TCA,THC
• 00810174470956: 6-Panel T-Swab; AMP-COC-OPI;MET-THC-OXY, 5Test/ Box
• 00810174470918: Prime Screen® 6-Panel Card; 2 per box; AMP,BZO,COC,MET,OPI,THC