Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- One Step 12 Panel DOA Cup + Adulteration Test (12.11.1) - MOP300 OXY100 BZO300 MOP2000 MET500 AMP500 COC150 THC50 MDMA500 BUP10 BAR300 MTD300 + Cre/pH/Oxi FDA UDI
- Model / Reference
- D12.11.1-1VA FDA UDI
- Description
- One Step 12 Panel DOA Cup + Adulteration Test (12.11.1) - MOP300 OXY100 BZO300 MOP2000 MET500 AMP500 COC150 THC50 MDMA500 BUP10 BAR300 MTD300 + Cre/pH/Oxi FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00722066004906 FDA UDI
- FDA Product Code
- NGL FDA UDIPTG FDA UDINFY FDA UDIPTH FDA UDINFW FDA UDINFT FDA UDINGG FDA UDINFV FDA UDIDJG FDA UDIDNK FDA UDIDJR FDA UDIDIS FDA UDILDJ FDA UDIDIO FDA UDIDKZ FDA UDIDJC FDA UDIJXM FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 FDA UDI862.3620 FDA UDI862.3250 FDA UDI862.3150 FDA UDI862.3870 FDA UDI862.3100 FDA UDI862.3610 FDA UDI862.3170 FDA UDI862.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Rapid Response by BTNX Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple drugs of abuse IVD, kit, rapid ICT, clinical.
- OneScreen — AMERICAN SCREENING, L.L.C. · U
- Identify® Diagnostics Drug Test Cards — MEDICAL DISTRIBUTION GROUP INC · Class II
- Healgen (Private Label) - 264 — Confirm Biosciences LLC · Class II
- STATDIP® — MICRO DISTRIBUTING, L.C · Class II
- STATDIP® — MICRO DISTRIBUTING, L.C · Class II
- Precision Plus — AMERICAN SCREENING, L.L.C. · Class II
- DrugCheck — Express Diagnostic Int'l, Inc. · Class II
- QuickProfile™ THC Test Strip — LumiQuick Diagnostics, Inc. · Class II
Cleared under the same submission
K181768 also covers:
- AssureTech Panel Dip Tests — ASSURE TECH. (HANGZHOU) CO., LTD.
- AssureTech Quick Cup Tests — ASSURE TECH. (HANGZHOU) CO., LTD.
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- THE SOLUTION — Sakar International, Inc.
- THE SOLUTION — Sakar International, Inc.
- THE SOLUTION — Sakar International, Inc.
- THE SOLUTION — Sakar International, Inc.
K182738 also covers:
- L-Cup — BTNX Inc
- L-Cup — BTNX Inc
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- Rapid Response — BTNX Inc
- Discover — Hangzhou AllTest Biotech Co., Ltd.
- Discover — Hangzhou AllTest Biotech Co., Ltd.
- Discover Multi-Drug 8 Drugs Rapid Test Cup(Urine) — Hangzhou AllTest Biotech Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BTNX Inc
Sources (1)
- FDA UDI a3d47e5e-7613-4f3d-a334-9890661f6b76 34 fields · synced Jun 8, 2026