Duns Number:483609579
Device Description: A convenience kit consisting of 2 Clearblue Digital Pregnancy Test and 2 Clearblue Rapid D A convenience kit consisting of 2 Clearblue Digital Pregnancy Test and 2 Clearblue Rapid Detection Pregnancy Test devices
Catalog Number
-
Brand Name
Clearblue
Version/Model Number
Digital and Rapid Pregnancy Tests
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
K060128,K110433,K060128,K110433
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
a41f3d38-a390-4e05-b040-ff2d06fbeb3b
Public Version Date
January 28, 2020
Public Version Number
3
DI Record Publish Date
March 16, 2018
Package DI Number
10633472601542
Quantity per Package
12
Contains DI Package
00633472601545
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |