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Easy@Home THC Single Drug Screen Test (15 tests kit)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Easy@Home THC Single Drug Screen Test (15 tests kit) FDA UDI
- Generic Name
- Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical FDA UDI
- Model / Reference
- EDTH-114 FDA UDI
Identifiers
- Catalog Number
- EDTH-114-15 FDA UDI
- Primary DI / UDI-DI
- 00810038630151 FDA UDI
- 510(k) Number
- K121557 FDA UDI
- FDA Product Code
- LDJ FDA UDI
- GMDN Term
- Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3870 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
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
Easy@Home THC Single Drug Screen Test (15 tests kit) by Easy Healthcare Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical.
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- AccuSign® DOA 3 TH/O/C card — PRINCETON BIOMEDITECH CORP. · Class II
- Identify® Diagnostics Drug Test Cards — MEDICAL DISTRIBUTION GROUP INC · Class II
- U-Catch Marijuana Multi-Level Drug Test Card(Colloidal Gold) — Eterbio, Inc. · Class II
- Welcheck Marijuana(THC) Urine Test Dipcard — Safecare Biotech (Hangzhou) Co., Ltd. · Class II
Cleared under the same submission
K121557 also covers:
- Easy@Home Single Drug Screen Test (Cannabinoids Urine Test) (20 tests/kit) — EASY HEALTHCARE CORPORATION
- Easy@Home Single Drug Screen Test (Cannabinoids Urine Test) (5 tests/kit) — EASY HEALTHCARE CORPORATION
- Easy@Home THC Single Drug Screen Test (10 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home THC Single Drug Screen Test (15 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home THC Single Drug Screen Test (20 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home THC Single Drug Screen Test (25 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home THC Single Drug Screen Test (5 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home THC Single Drug Screen Test (6 tests kit) — EASY HEALTHCARE CORPORATION
- Easy@Home TRA Single Drug Screen Test (25 tests kit) — EASY HEALTHCARE CORPORATION
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
- Easy Healthcare Corporation
Sources (1)
- FDA UDI 34331a4c-afa3-4564-8d98-d8400fb3e3be 34 fields · synced Jun 1, 2026