Identity
- Trade Name
- Discover milti-drug 7 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/OXY100/COC150/MET500/BZO300/AMP500/BUP10 + (CRE/SG/PH) FDA UDI
- Model / Reference
- DUA-A177C-A3 A1617 FDA UDI
- Description
- 1T,FDA,CLIA waived, MOP(OPI)300/OXY100/COC150/MET500/BZO300/AMP500/BUP10 + (CRE/SG/PH) FDA UDI
Identifiers
- Catalog Number
- DISP-DUD774N$ FDA UDI
- Primary DI / UDI-DI
- 16936983149744 FDA UDI
- 510(k) Number
- K182738 FDA UDI
- FDA Product Code
- NGL FDA UDIJXM FDA UDINFT FDA UDIDJC FDA UDIDJG FDA UDINFY 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 UDI862.3170 FDA UDI862.3100 FDA UDI862.3610 FDA UDI862.3250 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-drug 7 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 07bf5c18-77ea-4da6-9a2d-eaa2dd7a65d2 35 fields · synced May 30, 2026