Duns Number:483609579
Device Description: A convenience kit consisting of 1 Clearblue Pregnancy Test with Smart Countdown device and A convenience kit consisting of 1 Clearblue Pregnancy Test with Smart Countdown device and 1 Clearblue Rapid Detection Pregnancy Test devices
Catalog Number
-
Brand Name
Clearblue
Version/Model Number
Pregnancy Test Combo Pack
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
2bc3a87e-01bc-48e2-81a2-20da80de4062
Public Version Date
October 06, 2022
Public Version Number
5
DI Record Publish Date
September 14, 2016
Package DI Number
10633472601153
Quantity per Package
24
Contains DI Package
00633472601156
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 |