Identity
- Trade Name
- OPI/COC/THC Tests Panel FDA UDI
- Generic Name
- Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical FDA UDI
- Model / Reference
- 1.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06952804801946 FDA UDI
- 510(k) Number
- K170049 FDA UDI
- FDA Product Code
- NFY FDA UDINGL FDA UDINFW FDA UDI
- GMDN Term
- Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3250 FDA UDI862.3650 FDA UDI862.3870 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
No
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: Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinicalCocaine/cocaine metabolite IVD, kit, rapid ICT, clinicalOpiate/opiate metabolite IVD, kit, rapid ICT, clinical
OPI/COC/THC Tests Panel 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
K170049 also covers:
- AssureTech Panel Dip Tests — ASSURE TECH. (HANGZHOU) CO., LTD.
- AssureTech Panel Dip Tests — ASSURE TECH. (HANGZHOU) CO., LTD.
- AssureTech Quick Cup Test — ASSURE TECH. (HANGZHOU) CO., LTD.
- AssureTech Quick Cup Test — ASSURE TECH. (HANGZHOU) CO., LTD.
- Benzodiazepines Panel Dip — ASSURE TECH. (HANGZHOU) CO., LTD.
- DOA Urine Cup 004 — ASSURE TECH. (HANGZHOU) CO., LTD.
- DOA Urine Cup 004 — ASSURE TECH. (HANGZHOU) CO., LTD.
- Ecstasy Panel Dip — ASSURE TECH. (HANGZHOU) CO., LTD.
- Morphine300 Panel Dip — ASSURE TECH. (HANGZHOU) CO., LTD.
- HYSEN Multi-Panel Drug Test Dip Card — HYSEN INC
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 4af631d0-cae4-4a7a-972b-5d9460ea4fc8 33 fields · synced May 30, 2026