Rapid Response One Step DOA Cup

GUDID 00722066004500

BTNX Inc

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

• Primary Device ID: 00722066004500
• NIH Device Record Key: d1e5fc62-9ac4-4112-bdd5-b3baa7380095
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rapid Response One Step DOA Cup
• Version Model Number: D10.14-1V
• Company DUNS: 251005005
• Company Name: BTNX Inc
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00722066004500 [Primary]
GS1	00722066004517 [Unit of Use]
GS1	10722066004514 [Package]; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180349

FDA Product Code

• PTH: Test, Barbiturate, 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: 2018-08-30
• Device Publish Date: 2018-07-30

Devices Manufactured by BTNX Inc

• 00722066008294 - Rapid Response: 2024-08-23 12 Panel DOA Cup (12.11) - MOP300 OXY100 BZO300 OPI2000 MET1000 AMP1000 COC300 THC50 MDMA500 BUP10 BAR300 MTD300
• 10722066008345 - Rapid Response: 2024-08-23 One Step 6 Panel DOA Cup (6.65) - AMP1000, BUP10, BZO300, COC300, OPI2000, OXY100
• 00722066009017 - Rapid Response: 2024-08-23 10 Panel DOA Cup (10.46) -OXY100 MDMA500 COC150 BZO300 MTD300 BUP10 MET500 MOR300 AMP500 THC50
• 00722066008249 - Rapid Response: 2024-08-22 Rapid Response Fentanyl Test Cassette
• 00722066008379 - Rapid Response: 2024-08-22 Rapid Response Saliva Drug Test (COT)
• 00722066008614 - Rapid Response: 2024-08-22 D4.59-1VF- AMP1000 COC300 MOP2000 PCP25
• 00722066008621 - Rapid Response: 2024-08-22 Rapid Response Fentanyl Test Cassette
• 00722066008850 - Rapid Response: 2024-08-22 D9.28-1VF- MTD300 EDDP300 MOP300 BUP10 BZO300 COC300 AMP1000 BAR300 THC50