Duns Number:004238200
Device Description: Clearblue 6 Day Visual Pregnancy 2ct US (CB17)
Catalog Number
-
Brand Name
Clearblue
Version/Model Number
Early Detection Pregnancy Test
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
-
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
e0ee44fb-a038-4e66-8774-8e072b1cf381
Public Version Date
October 22, 2021
Public Version Number
2
DI Record Publish Date
February 24, 2020
Package DI Number
10633472601931
Quantity per Package
24
Contains DI Package
00633472601934
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 241 |
| U | Unclassified | 1 |