Easy@Home Multi-Drug Test Cup (25 tests kit)

GUDID 10850253007540

25 tests kit;5-Panel T-Cup;COC/THC/OPI/AMP/MET

EASY HEALTHCARE CORPORATION

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10850253007540
NIH Device Record Key4abcdfed-2a39-4cbb-ad02-7a043a640e25
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Multi-Drug Test Cup (25 tests kit)
Version Model NumberECDOA-254
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
GS100850253007543 [Primary]
GS110850253007540 [Package]
Contains: 00850253007543
Package: [4 Units]
In Commercial Distribution
GS130850253007544 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LAFGas Chromatography, Methamphetamine

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 (25 tests kit)]

1085025300760125 tests kit;14-Panel T-Cup 3-AD; COC/THC/OPI/BZO/MET/TCA/OXY/BUP/BAR/MTD/AMP/MDMA/PCP/PPX)OX/SG
1085025300758825 tests kit;12 Panel-T cup; AMP/BAR/BZO/BUP/COC/MDMA/MET/MTD/MOP/OXY/THC/PCP
1085025300756425 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP
1085025300754025 tests kit;5-Panel T-Cup;COC/THC/OPI/AMP/MET
1081003863135325 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP
1081003863133925 tests kit;14-Panel T-Cup 3-AD; COC/THC/OPI/BZO/MET/TCA/OXY/BUP/BAR/MTD/AMP/MDMA/PCP/PPX)OX/SG

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