Duns Number:006961700
Device Description: A convenience kit consisting of 7 up&up One Step Ovulation Predictor Tests + 1 up&up Early A convenience kit consisting of 7 up&up One Step Ovulation Predictor Tests + 1 up&up Early Result Pregnancy Test
Catalog Number
-
Brand Name
Up & Up
Version/Model Number
One Step Ovulation Predictor PLUS Early Result Pregnancy Test
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 17, 2020
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
K002867,K042280,K002867,K042280
Product Code
CEP
Product Code Name
Radioimmunoassay, Luteinizing Hormone
Public Device Record Key
52c8b7ff-53b6-4cc5-91ec-3f90c3d97276
Public Version Date
July 20, 2020
Public Version Number
6
DI Record Publish Date
February 12, 2018
Package DI Number
10492450308633
Quantity per Package
12
Contains DI Package
00492450308636
Package Discontinue Date
July 17, 2020
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. | 52 |
| U | Unclassified | 12 |