One-Step W734P

GUDID 00841824104358

DOA 3 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived, COC/MOR/THC

W.H.P.M. INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00841824104358
• NIH Device Record Key: cd3de041-573f-4936-8c2b-8cf384a60e01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One-Step
• Version Model Number: W734
• Catalog Number: W734P
• Company DUNS: 602085672
• Company Name: W.H.P.M. INC.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841824104341 [Unit of Use]
GS1	00841824104358 [Primary]

FDA Product Code

• LDJ: Enzyme Immunoassay, Cannabinoids

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: 2019-09-06
• Device Publish Date: 2019-08-29

On-Brand Devices [One-Step]

• 00841824104273: DOA Single Test Dip Card, 25Pcs/Box, CLIA Waived TCA
• 00841824104433: DOA 6 in 1 Test Push Button Cup, 25Pcs/Box, AMP/COC/mAMP/MOR/PCP/THC
• 00841824104419: DOA 5 in 1 Test Push Button Cup, 25Pcs/Box, AMP/COC/OPI/PCP/THC
• 00841824104525: DOA 8 in 1 Test Dip Card, Sealed Pouch, CLIA Waived, AMP/COC150/mAMP500/MDMA/OPI/OXY/PCP/THC
• 00841824104358: DOA 3 in 1 Test Dip Card, 25Pcs/Box, CLIA Waived, COC/MOR/THC