Identity
- Trade Name
- AssureTech Panel Dip Tests FDA UDI
- Generic Name
- Phencyclidine (PCP) IVD, kit, rapid ICT, clinical FDA UDI
- Model / Reference
- 1.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06952804801656 FDA UDI
- 510(k) Number
- K170049 FDA UDI
- FDA Product Code
- PTG FDA UDINGM FDA UDIPTH FDA UDINFV FDA UDINGL FDA UDINGG FDA UDINFY FDA UDINFW FDA UDINFT FDA UDI
- GMDN Term
- Phencyclidine (PCP) IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3620 FDA UDI862.3150 FDA UDI862.3170 FDA UDI862.3650 FDA UDI862.3610 FDA UDI862.3250 FDA UDI862.3870 FDA UDI862.3100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinicalCocaine/cocaine metabolite IVD, kit, rapid ICT, clinicalOpiate/opiate metabolite IVD, kit, rapid ICT, clinicalBarbiturate IVD, kit, rapid ICT, clinical
AssureTech Panel Dip Tests by Assure Tech. (hangzhou) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phencyclidine (PCP) IVD, kit, rapid ICT, clinical.
- SAFECUP II MULTIDRUG N5 — GERMAINE LABORATORIES, INC. · U
- BluRapids™ — MERCEDES MEDICAL LLC · Class II
- AccuSign® PCP card — PRINCETON BIOMEDITECH CORP. · U
- Status DS™ 9 card — PRINCETON BIOMEDITECH CORP. · Class II
- N/M — IDUN SOLUTIONS LLC · Class II
- AIMSCREEN PCP — GERMAINE LABORATORIES, INC. · U
- UScreen — Guangzhou Decheng Biotechnology Co., LTD · Class II
- AccuSign® PCP card — PRINCETON BIOMEDITECH CORP. · U
Cleared under the same submission
K170049 also covers:
- 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.
- OPI/COC/THC Tests Panel — ASSURE TECH. (HANGZHOU) CO., LTD.
- HYSEN Multi-Panel Drug Test Dip Card — HYSEN INC
Authorization Coverage (1 country)
Regulatory Authorizations
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 d6c7b81e-6ff6-4cd3-9b42-3188565d003a 33 fields · synced May 30, 2026