Identity
- Trade Name
- Panel Dip FDA UDI
- Generic Name
- Barbiturate IVD, kit, rapid ICT, clinical FDA UDI
- Model / Reference
- 1.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06952804801083 FDA UDI
- 510(k) Number
- K151211 FDA UDI
- FDA Product Code
- DIS FDA UDIDJG FDA UDI
- GMDN Term
- Barbiturate IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3150 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Opiate/opiate metabolite IVD, kit, rapid ICT, clinicalBarbiturate IVD, kit, rapid ICT, clinical
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
K151211 also covers:
- Barbiturate Panel Dip — ASSURE TECH. (HANGZHOU) CO., LTD.
- Oxycodone Panel Dip — ASSURE TECH. (HANGZHOU) CO., LTD.
- Oxycodone Strip — ASSURE TECH. (HANGZHOU) CO., LTD.
- Quick Cup — ASSURE TECH. (HANGZHOU) CO., LTD.
- Secobarbital Strip — ASSURE TECH. (HANGZHOU) CO., LTD.
- Turn-Key Split Cup — 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 b7ec247f-9069-4fa3-b794-4e93b3d4db5b 33 fields · synced Jun 8, 2026