Duns Number:006961700
Device Description: A convenience kit consisting of 7 One-step Ovulation Tests and 1 One-step Pregnancy Test
Catalog Number
-
Brand Name
Up & Up
Version/Model Number
Combo Pack 7 Ovulation Tests + 1 Pregnancy Test
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 01, 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
-
Product Code
CEP
Product Code Name
Radioimmunoassay, Luteinizing Hormone
Public Device Record Key
a43abc53-8b1d-40f3-8c7a-0baa5d6da428
Public Version Date
July 15, 2020
Public Version Number
5
DI Record Publish Date
March 01, 2017
Package DI Number
10855606007086
Quantity per Package
15
Contains DI Package
00855606007089
Package Discontinue Date
January 01, 2020
Package Status
Not in Commercial Distribution
Package Type
Case Pack
| 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 |