Easy@Home Multi-Drug Test Cup (5 tests kit)

GUDID 10850253007557

5 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP

EASY HEALTHCARE CORPORATION

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Primary Device ID10850253007557
NIH Device Record Keyc0f777bd-b694-4d46-be60-42f075ccc13b
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Multi-Drug Test Cup (5 tests kit)
Version Model NumberECDOA-7124
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count5
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
GS100850253007550 [Primary]
GS110850253007557 [Package]
Contains: 00850253007550
Package: [16 Units]
In Commercial Distribution
GS130850253007551 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-11-12
Device Publish Date2016-09-15

On-Brand Devices [Easy@Home Multi-Drug Test Cup (5 tests kit)]

108502530075955 tests kit;14-Panel T-Cup 3-AD; COC/THC/OPI/BZO/MET/TCA/OXY/BUP/BAR/MTD/AMP/MDMA/PCP/PPX+OX/SG/
108502530075715 tests kit;12 Panel-T cup; AMP/BAR/BZO/BUP/COC/MDMA/MET/MTD/MOP/OXY/THC/PCP
108502530075575 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP
108502530075335 tests kit;5-Panel T-Cup;COC/THC/OPI/AMP/MET
308100386313645 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP
108100386313465 tests kit;14-Panel T-Cup 3-AD; COC/THC/OPI/BZO/MET/TCA/OXY/BUP/BAR/MTD/AMP/MDMA/PCP/PPX+OX/SG/
308100386311115 tests kit;5-Panel T-Cup;COC/THC/OPI/AMP/MET
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