Duns Number:006961700
Device Description: A convenience kit consisting of 10 Ovulation Test devices and 1 One Step Pregnancy Test.
Catalog Number
-
Brand Name
Up & Up
Version/Model Number
Early Ovulation Test
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
378f9d70-d7e4-4b70-9741-de448f19caf4
Public Version Date
January 22, 2020
Public Version Number
1
DI Record Publish Date
January 14, 2020
Package DI Number
10829576076700
Quantity per Package
12
Contains DI Package
00829576076703
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. | 52 |
| U | Unclassified | 12 |