Identity
- Trade Name
- Buprenorphine/Methadone Quick Cup FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, kit, rapid ICT, clinical FDA UDI
- Model / Reference
- 1.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06952804801403 FDA UDI
- 510(k) Number
- K152025 FDA UDI
- FDA Product Code
- DJR FDA UDIDJG FDA UDI
- GMDN Term
- Opiate/opiate metabolite IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3620 FDA UDI862.3650 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Opiate/opiate metabolite IVD, kit, rapid ICT, clinicalMethadone IVD, kit, rapid ICT, clinical
Buprenorphine/Methadone Quick Cup by Assure Tech. (hangzhou) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Methadone IVD, kit, rapid ICT, clinical.
- RAPID DIAGNOSTICS METHADONE TEST STRIP KIT (50) — RAPID DIAGNOSTICS INC · Class II
- BluRapids™ — MERCEDES MEDICAL LLC · Class II
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD · Class II
- N/M — IDUN SOLUTIONS LLC · Class II
- UScreen — Guangzhou Decheng Biotechnology Co., LTD · Class II
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD · Class II
- Amazewell — Guangzhou Decheng Biotechnology Co., LTD · Class II
- UScreen Oral — Guangzhou Decheng Biotechnology Co., LTD · Class II
Cleared under the same submission
K152025 also covers:
- Buprenorphine Panel Dip — ASSURE TECH. (HANGZHOU) CO., LTD.
- Buprenorphine Strip — ASSURE TECH. (HANGZHOU) CO., LTD.
- Buprenorphine/Methadone Panel Dip — ASSURE TECH. (HANGZHOU) CO., LTD.
- Buprenorphine/Methadone Turnkey Split Cup — ASSURE TECH. (HANGZHOU) CO., LTD.
- Methadone Panel Dip — ASSURE TECH. (HANGZHOU) CO., LTD.
- Methadone Strip — ASSURE TECH. (HANGZHOU) 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
- Assure Tech. (hangzhou) Co., Ltd.
Sources (1)
- FDA UDI cfbd9f75-e6ad-4215-8a6f-3420b792271c 33 fields · synced May 31, 2026