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Easy@Home THC Single Drug Screen Test (12 tests kit)

FDA UDI

Class II (US FDA UDI)

by Easy Healthcare Corporation

Identity

Trade Name
Easy@Home THC Single Drug Screen Test (12 tests kit) FDA UDI
Generic Name
Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical FDA UDI
Device Name
12 tests kit;THC Single Panel FDA UDI
Model / Reference
EDTH-114 FDA UDI
Description
12 tests kit;THC Single Panel FDA UDI

Identifiers

Catalog Number
EDTH-114-12 FDA UDI
Primary DI / UDI-DI
00855944007642 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
Not 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

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

Easy@Home THC Single Drug Screen Test (12 tests kit) by Easy Healthcare Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K121557 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Easy Healthcare Corporation

Sources (1)

  • FDA UDI 10ae9fe3-0d0b-4ebe-86ce-64fcccff7bc4 36 fields · synced May 30, 2026