Identity
- Trade Name
- Buprenorphine/Methadone Panel Dip 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
- 06952804801397 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 Panel Dip by Assure Tech. (hangzhou) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 Quick Cup — 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 |
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Manufacturer
- Manufacturer
- Assure Tech. (hangzhou) Co., Ltd.
Sources (1)
- FDA UDI a8c533ff-a6b6-4dcd-89a0-6d4fcb0d301d 33 fields · synced May 30, 2026