Easy@Home Nicotine Urine Test (5 tests one kit) ECOT-114-5

GUDID 20810038636447

5 tests kit; Nicotine Urine Test -COT

EASY HEALTHCARE CORPORATION

Cotinine IVD, kit, rapid ICT, clinical
Primary Device ID20810038636447
NIH Device Record Keyd7fbef04-8e0e-41a2-83f9-a86a7e20db08
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Nicotine Urine Test (5 tests one kit)
Version Model NumberECOT-114
Catalog NumberECOT-114-5
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count5
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
GS100810038636443 [Primary]
GS120810038636447 [Package]
Contains: 00810038636443
Package: CARTONS [12 Units]
In Commercial Distribution
GS140810038636441 [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 Date2024-07-25
Device Publish Date2024-07-17

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