Duns Number:483609579
Device Description: ADOT Clearblue Advanced Ovulation 10ct March of Dimes Dual US
Catalog Number
-
Brand Name
Clearblue
Version/Model Number
Advanced Digital Ovulation 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
NGE
Product Code Name
Test, Luteinizing Hormone (Lh), Over The Counter
Public Device Record Key
741a6b1c-882d-4ff4-8396-be566c630e67
Public Version Date
June 17, 2019
Public Version Number
1
DI Record Publish Date
June 07, 2019
Package DI Number
00633472600715
Quantity per Package
12
Contains DI Package
00633472600425
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 |