Areta Multi-Drug Test Cup (6 tests kit) ACDOA-754-6

GUDID 00810038632988

Areta 5 Panel Drug Test Cup (6 Test Kit) - THC,COC,OPI2000,BZO,AMP

EASY HEALTHCARE CORPORATION

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00810038632988
NIH Device Record Keyd3a8c890-7d66-460f-b7d8-8ec53df802c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAreta Multi-Drug Test Cup (6 tests kit)
Version Model NumberACDOA-754
Catalog NumberACDOA-754-6
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count6
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
GS100810038632988 [Primary]
GS130810038632989 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-05
Device Publish Date2021-10-28

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