FDA UDI In Commercial Distribution 🇺🇸 United States

Easy@Home Ovulation Test Kit (15 LH Midstreams+5 HCG Midstreams)

DI: 00855944007086 · Model: EZW2-M , EZW1-M · EASY HEALTHCARE CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
20

Basic Information

Brand Name
Easy@Home Ovulation Test Kit (15 LH Midstreams+5 HCG Midstreams)
Primary DI
00855944007086
Version / Model
EZW2-M , EZW1-M
Catalog Number
EZM1-L15H5
Company Name
EASY HEALTHCARE CORPORATION
Labeler DUNS
080278407
Distribution Status
In Commercial Distribution
Device Count in Pkg
20
Record Status
Published
Publish Date
2018-07-01
Public Version
2
Public Version Date
2019-02-21
Public Version Status
Update
Public Device Record Key
ba7e74f4-0268-48bf-9c85-8866514fcfd3

Device Description

Easy@Home 15 Ovulation (LH) and Plus 5 Pregnancy (hCG) Test Sticks

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

GMDN Terms

Code Name
60862 Natural conception assistance kit

Identifiers

Type ID
Package 10855944007083
Primary 00855944007086
Unit of Use 30855944007087