Identity
- Trade Name
- Easy@Home Nicotine Urine Test (5 tests one kit) FDA UDI
- Generic Name
- Cotinine IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- 5 tests kit; Nicotine Urine Test -COT FDA UDI
- Model / Reference
- ECOT-114 FDA UDI
- Description
- 5 tests kit; Nicotine Urine Test -COT FDA UDI
Identifiers
- Catalog Number
- ECOT-114-5 FDA UDI
- Primary DI / UDI-DI
- 00810038636443 FDA UDI
- FDA Product Code
- MRS FDA UDI
- GMDN Term
- Cotinine IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3220 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cotinine IVD, kit, rapid ICT, clinical
Easy@Home Nicotine Urine Test (5 tests one kit) by Easy Healthcare Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Rapid Response — BTNX Inc · Class I
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Easy Healthcare Corporation
Sources (1)
- FDA UDI d7fbef04-8e0e-41a2-83f9-a86a7e20db08 34 fields · synced May 30, 2026