Duns Number:483609579
Device Description: COTS Clearblue 25ct Ovulation + CB12 3ct Digital Pregnancy Bundle
Catalog Number
-
Brand Name
Clearblue
Version/Model Number
Connected Ovulation Test System + Clearblue Pregnancy Test with Smart Countdown
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 02, 2019
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
CEP
Product Code Name
Radioimmunoassay, Luteinizing Hormone
Public Device Record Key
cac75899-f76d-4795-a698-2ff10f54bcf3
Public Version Date
December 03, 2019
Public Version Number
4
DI Record Publish Date
May 24, 2018
Package DI Number
10633472601344
Quantity per Package
1
Contains DI Package
00633472601347
Package Discontinue Date
December 02, 2019
Package Status
Not in Commercial Distribution
Package Type
Individual Pack
| 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 |