Easy@Home THC Single Drug Screen Test (15 tests kit) EDTH-114-15

GUDID 30810038630152

EASY HEALTHCARE CORPORATION

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Primary Device ID30810038630152
NIH Device Record Key34331a4c-afa3-4564-8d98-d8400fb3e3be
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home THC Single Drug Screen Test (15 tests kit)
Version Model NumberEDTH-114
Catalog NumberEDTH-114-15
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count15
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
GS100810038630151 [Primary]
GS130810038630152 [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 Date2020-07-06
Device Publish Date2020-06-26

On-Brand Devices [Easy@Home THC Single Drug Screen Test (15 tests kit)]

00850253007253EDTH-114-15
30810038630152EDTH-114
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