Easy@Home Single Drug Screen Test (Marijuanan Urine Test) EDTH-114-12

GUDID 30810038633627

Easy@Home Single Drug Screen Test (Marijuanan Urine Test)- 12 tests kit

EASY HEALTHCARE CORPORATION

Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID30810038633627
NIH Device Record Key66792913-3bff-4c43-946a-173286105e0d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Single Drug Screen Test (Marijuanan Urine Test)
Version Model NumberEDTH-114
Catalog NumberEDTH-114-12
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count12
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100810038633626 [Primary]
GS130810038633627 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDJEnzyme Immunoassay, Cannabinoids

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-11
Device Publish Date2022-04-01

Devices Manufactured by EASY HEALTHCARE CORPORATION

10810038638154 - Easy@Home Blood Pressure Monitor 2025-08-08
10810038638857 - Easy@Home Digital Basal Thermometer2025-08-08
00810038638874 - Easy@Home Smart Basal Thermometer2025-08-08
00810038638881 - Easy@Home Smart Basal Thermometer2025-08-08
00810038638898 - Easy@Home Digital Basal Thermometer2025-08-08
00810038638904 - Easy@Home Digital Basal Thermometer2025-08-08
00810038638928 - Premom Smart Basal Thermometer2025-08-08
00810038638935 - Easy@Home Digital Thermometer2025-08-08

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.