Easy@Home Pregnancy Test Midstream (10 tests kit) EZW1-M

GUDID 10850253007809

10 tests kit; HCG mistreams

EASY HEALTHCARE CORPORATION

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10850253007809
NIH Device Record Key8d1a31b9-9e3f-4443-b7b1-443f4dc7df5d
Commercial Distribution Discontinuation2018-06-26
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEasy@Home Pregnancy Test Midstream (10 tests kit)
Version Model NumberEZM1-H10
Catalog NumberEZW1-M
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count10
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
GS100850253007802 [Primary]
GS110850253007809 [Package]
Contains: 00850253007802
Package: Carton [70 Units]
Discontinued: 2018-06-26
Not in Commercial Distribution
GS130850253007803 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCXKit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-07-06
Device Publish Date2016-12-23

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