Easy@Home Ovulation Test Kit (40 LH strips + 10 HCG strips ) EZ-WS4010

GUDID 10810038630288

40 LH strips + 10 HCG strips ; Ovulation Test Kit

EASY HEALTHCARE CORPORATION

Natural conception assistance kit
Primary Device ID10810038630288
NIH Device Record Key482afbe0-175e-40ff-a428-60995936b715
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Ovulation Test Kit (40 LH strips + 10 HCG strips )
Version Model NumberEZW2-S, EZW1-S
Catalog NumberEZ-WS4010
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count50
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
GS100810038630281 [Primary]
GS110810038630288 [Package]
Contains: 00810038630281
Package: Carton [80 Units]
In Commercial Distribution
GS190810038630284 [Unit of Use]

FDA Product Code

CEPRadioimmunoassay, Luteinizing Hormone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

On-Brand Devices [Easy@Home Ovulation Test Kit (40 LH strips + 10 HCG strips )]

1085025300763240 LH strips + 10 HCG strips
1081003863028840 LH strips + 10 HCG strips ; Ovulation Test Kit

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