FDA UDI Not in Commercial Distribution 🇺🇸 United States

Easy@Home Ovulation Test Kit (10 LH Midstreams+ 2 HCG Midstreams)

DI: 00850253007666 · Model: EZM2M3-L10H2 · EASY HEALTHCARE CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
12

Basic Information

Brand Name
Easy@Home Ovulation Test Kit (10 LH Midstreams+ 2 HCG Midstreams)
Primary DI
00850253007666
Version / Model
EZM2M3-L10H2
Catalog Number
EZW2-M , EZW1-M
Company Name
EASY HEALTHCARE CORPORATION
Labeler DUNS
080278407
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
12
Record Status
Published
Publish Date
2016-09-15
Public Version
5
Public Version Date
2019-02-21
Public Version Status
Update
Public Device Record Key
327ee0ba-8d23-45be-b4fa-33f3541161de
Distribution End Date
2018-06-26

Device Description

10 LH midstreams + 2 HCG midstreams

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LCX Kit, Test, Pregnancy, Hcg, Over The Counter
CEP Radioimmunoassay, Luteinizing Hormone

GMDN Terms

Code Name
60862 Natural conception assistance kit

Identifiers

Type ID
Package 10850253007663
Primary 00850253007666
Unit of Use 30850253007667