Duns Number:483609579
Device Description: A convenience kit consisting of 7 Clearblue Easy Ovulation Test device and 1 Clearblue Pre A convenience kit consisting of 7 Clearblue Easy Ovulation Test device and 1 Clearblue Pregnancy Test with Smart Countdown device
Catalog Number
N/A
Brand Name
Clearblue Easy Ovulation Kit
Version/Model Number
HOT / CB12
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 2016
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,K981271,K060128,K981271
Product Code
CEP
Product Code Name
Radioimmunoassay, Luteinizing Hormone
Public Device Record Key
59a6d66c-3c89-4e3a-8806-c739e9809e87
Public Version Date
February 21, 2019
Public Version Number
4
DI Record Publish Date
June 30, 2016
Package DI Number
00633472600548
Quantity per Package
6
Contains DI Package
00633472155642
Package Discontinue Date
October 31, 2016
Package Status
Not 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 |