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

GUDID 10810038630622

5 tests per kit;10-Panel Dip Card; AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA

EASY HEALTHCARE CORPORATION

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10810038630622
NIH Device Record Key0b844615-0b63-4422-828c-350d0fc5cc7f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Multi-Drug Screen Test (5 tests/kit)
Version Model NumberEDOAP-3104
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
GS100810038630625 [Primary]
GS110810038630622 [Package]
Contains: 00810038630625
Package: Carton [36 Units]
In Commercial Distribution
GS130810038630626 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJREnzyme Immunoassay, Methadone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-25
Device Publish Date2022-02-17

Devices Manufactured by EASY HEALTHCARE CORPORATION

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10810038638857 - Easy@Home Digital Basal Thermometer2025-08-08
00810038638874 - Easy@Home Smart Basal Thermometer2025-08-08
00810038638881 - Easy@Home Smart Basal Thermometer2025-08-08
00810038638898 - Easy@Home Digital Basal Thermometer2025-08-08
00810038638904 - Easy@Home Digital Basal Thermometer2025-08-08
00810038638928 - Premom Smart Basal Thermometer2025-08-08
00810038638935 - Easy@Home Digital Thermometer2025-08-08

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