Duns Number:080278407
Device Description: 50 tests kit; LH test strips in bulk package
Catalog Number
-
Brand Name
Easy@Home Ovulation Test Strip (50 tests-bulk pack)
Version/Model Number
EZW2-S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 26, 2018
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CEP
Product Code Name
Radioimmunoassay, Luteinizing Hormone
Public Device Record Key
d94b2789-fe98-4d26-a370-e3c4ab2cc00c
Public Version Date
February 21, 2019
Public Version Number
4
DI Record Publish Date
December 23, 2016
Package DI Number
10850253007830
Quantity per Package
100
Contains DI Package
00850253007833
Package Discontinue Date
June 26, 2018
Package Status
Not in Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 47 |