Areta Multi-Drug Test Cup (25 tests kit) ACDOA-1144-25

GUDID 10810038630646

Areta 14-Panel Drug Test Cup (25 Test Kit): AMP,BAR,BUP,BZO,COC,MAMP (MET),MDMA,MTD,OPI2000 (OPI),OXY,PCP,PPX,TCA,THC

EASY HEALTHCARE CORPORATION

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10810038630646
NIH Device Record Key984d3181-39a2-4b94-b29c-836ac32b92f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAreta Multi-Drug Test Cup (25 tests kit)
Version Model NumberACDOA-1144
Catalog NumberACDOA-1144-25
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
GS100810038630649 [Primary]
GS110810038630646 [Package]
Contains: 00810038630649
Package: Carton [4 Units]
In Commercial Distribution
GS130810038630640 [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 Date2020-07-07
Device Publish Date2020-06-29

On-Brand Devices [ Areta Multi-Drug Test Cup (25 tests kit)]

10855944007212Areta 14-Panel Drug Test Cup (25 Test Kit): AMP,BAR,BUP,BZO,COC,MAMP (MET),MDMA,MTD,OPI2000 (OP
10810038630646Areta 14-Panel Drug Test Cup (25 Test Kit): AMP,BAR,BUP,BZO,COC,MAMP (MET),MDMA,MTD,OPI2000 (OP
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