Duns Number:483609579
Device Description: A convenience kit consisting of 10 Clearblue Easy Ovulation Test device and 1 Clearblue Ra A convenience kit consisting of 10 Clearblue Easy Ovulation Test device and 1 Clearblue Rapid Dectection Pregnancy Test.
Catalog Number
-
Brand Name
Clearblue
Version/Model Number
Easy 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
K110433,K981271,K110433,K981271
Product Code
CEP
Product Code Name
Radioimmunoassay, Luteinizing Hormone
Public Device Record Key
36627971-f9b5-482b-ad7f-743279d642c7
Public Version Date
March 15, 2019
Public Version Number
5
DI Record Publish Date
November 16, 2016
Package DI Number
10633472601023
Quantity per Package
6
Contains DI Package
00633472601026
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 |