Duns Number:483609579
Device Description: A convenience kit consisting of 1 Clearblue Digital Pregnancy Test with Weeks Estimator de
Catalog Number
-
Brand Name
Clearblue Pregnancy Test Combo pack
Version/Model Number
CB9a / CB11
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 28, 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
-
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
cf23367c-40d2-4e9c-ae14-defb1dee18a1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 30, 2016
Package DI Number
10633472600262
Quantity per Package
24
Contains DI Package
00633472600265
Package Discontinue Date
January 28, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |