Duns Number:051957769
Device Description: HOT Visual Ovulation Stick 7 Ct Walmart Equate Early
Catalog Number
-
Brand Name
Equate
Version/Model Number
Early Ovulation Test
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 27, 2019
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
38543027-c519-44f3-9e8f-4648b17d50ff
Public Version Date
September 30, 2019
Public Version Number
2
DI Record Publish Date
March 04, 2019
Package DI Number
10078742095599
Quantity per Package
24
Contains DI Package
00078742095592
Package Discontinue Date
September 27, 2019
Package Status
Not in Commercial Distribution
Package Type
Shipping case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |