Duns Number:483609579
Device Description: A convenience kit consisting of 2 Clearblue Digital Pregnancy Test devices and 8 Clearblue A convenience kit consisting of 2 Clearblue Digital Pregnancy Test devices and 8 Clearblue Rapid Detection Pregnancy Test devices
Catalog Number
-
Brand Name
Clearblue
Version/Model Number
Rapid and Digital Detection 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
53bce128-1623-46ee-85d1-e47e0c8641f1
Public Version Date
June 21, 2021
Public Version Number
1
DI Record Publish Date
June 13, 2021
Package DI Number
10633472602051
Quantity per Package
6
Contains DI Package
00633472602054
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 |