Easy@Home THC Single Drug Screen Test (20 tests kit) EDTH-114-20

GUDID 10855944007465

20 tests kit;THC Single Panel

EASY HEALTHCARE CORPORATION

Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10855944007465
NIH Device Record Key022b4a7c-913b-4bda-9d43-1dd05a25d7c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home THC Single Drug Screen Test (20 tests kit)
Version Model NumberEDTH-114
Catalog NumberEDTH-114-20
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count20
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100855944007468 [Primary]
GS110855944007465 [Package]
Contains: 00855944007468
Package: Carton [35 Units]
In Commercial Distribution
GS130855944007469 [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 Date2018-07-27
Device Publish Date2018-06-26

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