Easy@Home Multi-Drug Screen Test (25 tests kit) EDOAP-144-25

GUDID 30810038631128

25 tests kit;4-Panel Dip Card; COC/THC/OPI/MET

EASY HEALTHCARE CORPORATION

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Primary Device ID30810038631128
NIH Device Record Keyf8a8628b-dc99-4801-8472-59766a330c2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Multi-Drug Screen Test (25 tests kit)
Version Model NumberEDOAP-144
Catalog NumberEDOAP-144-25
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count25
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
GS100810038631127 [Primary]
GS110810038631124 [Package]
Contains: 00810038631127
Package: Carton [20 Units]
In Commercial Distribution
GS130810038631128 [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

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