Duns Number:545868502
Device Description: The convenience kit consisting of 5 Ovulation Test device and 1 Pregnancy Test devices.
Catalog Number
-
Brand Name
Smilereader ovulation test kit
Version/Model Number
81002
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
OIE
Product Code Name
Urine Collection Kit (Excludes Hiv Testing)
Public Device Record Key
fbc9176e-3465-4d70-8778-4ab86d38b84c
Public Version Date
February 21, 2019
Public Version Number
3
DI Record Publish Date
August 15, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |
| U | Unclassified | 1 |