Areta Cotinine Test Strip(25tests one kit) ASCOT-114-25C25

GUDID 30810038634662

25 tests kit; COT Single Drug Screen Test

EASY HEALTHCARE CORPORATION

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Primary Device ID30810038634662
NIH Device Record Key7cc16fad-8f0c-4702-87ce-e54a8cd98e7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAreta Cotinine Test Strip(25tests one kit)
Version Model NumberASCOT-114C
Catalog NumberASCOT-114-25C25
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count25
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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
GS100810038634661 [Primary]
GS110810038634668 [Package]
Contains: 00810038634661
Package: carton [30 Units]
In Commercial Distribution
GS130810038634662 [Unit of Use]

FDA Product Code

MRSTest System, Nicotine, Cotinine, Metabolites

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-27
Device Publish Date2023-07-19

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