Duns Number:051957769
Device Description: A convenience kit consisting of 10 Equate Early Ovulation Test devices and 1 Equate One St A convenience kit consisting of 10 Equate Early Ovulation Test devices and 1 Equate One Step Pregnancy Test.
Catalog Number
-
Brand Name
Equate
Version/Model Number
Early Ovulation Kit
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K042280,K981271,K042280,K981271
Product Code
CEP
Product Code Name
Radioimmunoassay, Luteinizing Hormone
Public Device Record Key
45cee2d5-f5b2-4917-95f5-a4e2b6ac3469
Public Version Date
February 21, 2019
Public Version Number
2
DI Record Publish Date
October 01, 2018
Package DI Number
10681131240786
Quantity per Package
24
Contains DI Package
00681131240789
Package Discontinue Date
-
Package Status
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 |