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 (12.5.1) - AMP500 BAR300 BUP10 BZO300 COC150 MDMA500 MTD300 MET500 MOP2000 OXY100 THC50 PCP25 FDA UDI
- Model / Reference
- D12.5.1-1V FDA UDI
- Description
- One Step 12 Panel DOA Cup (12.5.1) - AMP500 BAR300 BUP10 BZO300 COC150 MDMA500 MTD300 MET500 MOP2000 OXY100 THC50 PCP25 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00722066004876 FDA UDI
- FDA Product Code
- NGM FDA UDINFW FDA UDINGI FDA UDINGG FDA UDIPTG FDA UDINFY FDA UDINFV FDA UDINGL FDA UDIPTH FDA UDINFT FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 862.3870 FDA UDI862.3640 FDA UDI862.3610 FDA UDI862.3620 FDA UDI862.3250 FDA UDI862.3170 FDA UDI862.3650 FDA UDI862.3150 FDA UDI862.3100 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
No
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 U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 U | Pending data |
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Manufacturer
- Manufacturer
- BTNX Inc
Sources (1)
- FDA UDI 355d134c-ac5c-4df6-b3a7-77e1107c4605 34 fields · synced Jun 1, 2026