Identity
- Trade Name
- Discover milti-drug12 drugs rapid test cup FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 1T,FDA,CLIA waived, MOP(OPI)300/MDMA500/OXY100/PCP25/COC150/MET500/MTD300/BAR300/BZO300/AMP500/TCA1000/BUP10+CRE/SG/PH FDA UDI
- Model / Reference
- DUA-A1127C-A3 A1617 FDA UDI
- Description
- 1T,FDA,CLIA waived, MOP(OPI)300/MDMA500/OXY100/PCP25/COC150/MET500/MTD300/BAR300/BZO300/AMP500/TCA1000/BUP10+CRE/SG/PH FDA UDI
Identifiers
- Catalog Number
- DISP-DUD20125N$ FDA UDI
- Primary DI / UDI-DI
- 16936983149751 FDA UDI
- 510(k) Number
- K182738 FDA UDI
- FDA Product Code
- DIO FDA UDIDNK FDA UDIDKZ FDA UDINFY FDA UDIDIS FDA UDIPTH FDA UDILFG FDA UDIDJC FDA UDINGL FDA UDILAF FDA UDILCM FDA UDINGI FDA UDIQAW FDA UDINGG FDA UDIDJR FDA UDIDJG FDA UDILDJ FDA UDIPTG FDA UDINFW FDA UDINFV FDA UDINFT FDA UDINGM 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
- 862.3250 FDA UDI862.3640 FDA UDI862.3100 FDA UDI862.3150 FDA UDI862.3910 FDA UDI862.3610 FDA UDI862.3650 FDA UDI862.3620 FDA UDI862.3870 FDA UDI862.3170 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
Discover milti-drug12 drugs rapid test cup by Hangzhou AllTest Biotech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Rapid Response — BTNX Inc
- Discover — Hangzhou AllTest Biotech Co., Ltd.
- Discover — 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 |
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Manufacturer
- Manufacturer
- Hangzhou AllTest Biotech Co., Ltd.
Sources (1)
- FDA UDI c01ca7d9-9d4d-4f4f-8aca-320bb1a7a2be 35 fields · synced May 31, 2026