Duns Number:080278407
Device Description: Premom Quantitative Ovulation Test strips; 20 tests per kit
Catalog Number
PMS2-S-20
Brand Name
Premom Quantitative Ovulation Predictor
Version/Model Number
PMS2-S
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
8de41e23-7429-4aba-a834-77f659b85fa9
Public Version Date
February 25, 2022
Public Version Number
1
DI Record Publish Date
February 17, 2022
Package DI Number
10810038631780
Quantity per Package
100
Contains DI Package
00810038631783
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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. | 47 |