Identity
- Trade Name
- DOA Urine Cup 004 FDA UDI
- Generic Name
- Methadone IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- AMP1000/BAR300/BZO300/COC300/MET1000/MOR2000/MTD300/OXY100/PCP25/THC50 FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- AMP1000/BAR300/BZO300/COC300/MET1000/MOR2000/MTD300/OXY100/PCP25/THC50 FDA UDI
Identifiers
- Catalog Number
- MD-U610 FDA UDI
- Primary DI / UDI-DI
- 06952804801892 FDA UDI
- 510(k) Number
- K170049 FDA UDI
- FDA Product Code
- NFT FDA UDILDJ FDA UDINGM FDA UDIPTG FDA UDINGL FDA UDINGG FDA UDINFY FDA UDINFV FDA UDIPTH FDA UDI
- GMDN Term
- Methadone IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3100 FDA UDI862.3870 FDA UDI862.3620 FDA UDI862.3650 FDA UDI862.3610 FDA UDI862.3250 FDA UDI862.3170 FDA UDI862.3150 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, clinicalBarbiturate IVD, kit, rapid ICT, clinical
DOA Urine Cup 004 by Assure Tech. (hangzhou) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Phencyclidine (PCP) IVD, kit, rapid ICT, clinical.
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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.
- 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
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 f46cac55-ee74-443d-8173-9fbf42724051 35 fields · synced May 30, 2026