Duns Number:483609579
Device Description: A convenience kit consisting of 15 Clearblue Advanced Digital Ovulation Tests and 2 Clearb A convenience kit consisting of 15 Clearblue Advanced Digital Ovulation Tests and 2 Clearblue Rapid Detection Pregnancy Tests
Catalog Number
-
Brand Name
Clearblue
Version/Model Number
Advanced Ovulation Kit
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
864b35c9-30d0-4178-8e90-aa1b2f8106c9
Public Version Date
February 10, 2022
Public Version Number
1
DI Record Publish Date
February 02, 2022
Package DI Number
10633472602181
Quantity per Package
6
Contains DI Package
00633472602184
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 |