L-Cup

GUDID 10722066006754

L-Cup Rapid Test w/ Adulteration (Urine). For the rapid detection of the following drugs in human urine: MOP300 OXY100 BZO300 MOP2000 MET500 AMP500 COC150 THC50 MDMA500 BUP10 BAR300 MTD300 + Cre/pH/Oxi

BTNX Inc

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

• Primary Device ID: 10722066006754
• NIH Device Record Key: efdd5c08-cc37-48c7-92ca-1ec7e523e2b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L-Cup
• Version Model Number: D12.11.1-1VLA
• Company DUNS: 251005005
• Company Name: BTNX Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00722066006757 [Primary]
GS1	10722066006754 [Package]; Contains: 00722066006757; Package: [25 Units]; In Commercial Distribution
GS1	20722066006751 [Package]; Contains: 00722066006757; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182738

FDA Product Code

• DKZ: Enzyme Immunoassay, Amphetamine

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: 2023-04-13
• Device Publish Date: 2023-04-05

On-Brand Devices [L-Cup]

• 10722066006747: L-Cup Home Rapid Test (Urine). For the rapid detection of the following drugs in human urine: AM
• 10722066006754: L-Cup Rapid Test w/ Adulteration (Urine). For the rapid detection of the following drugs in huma