Duns Number:006961700
Device Description: CB8 Digital Pregnancy Stick Target DPS Digital Early (ER)
Catalog Number
-
Brand Name
Up & Up
Version/Model Number
Digital Pregnancy Test
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 30, 2017
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
K060128,K060128,K060128
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
4d55eb92-5928-4f02-bd33-c31fbeed6277
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 15, 2016
Package DI Number
10492450303416
Quantity per Package
24
Contains DI Package
00492450303419
Package Discontinue Date
April 30, 2017
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 |