Rapid Response Multi-Drug Integrated Split Spec. Cup

GUDID 00722066005293

Multi-Drug Integrated Split Spec. Cup (D10.3-1K) - COC300 AMP1000 MET1000 THC50 OPI2000 PCP25 BAR300 BZO300 MTD300 MDMA500.

BTNX Inc

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

• Primary Device ID: 00722066005293
• NIH Device Record Key: f49abd54-48ba-4350-8696-6805b36dfc4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rapid Response Multi-Drug Integrated Split Spec. Cup
• Version Model Number: D10.3-1K
• Company DUNS: 251005005
• Company Name: BTNX 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: 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: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00722066005293 [Unit of Use]
GS1	10722066005290 [Primary]

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: 2023-05-08
• Device Publish Date: 2023-04-28

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