Duns Number:080278407
Device Description: Premom LH Ovulation Cassette (25 Pack of Individually-Sealed LH Urine Tests with Pipette)
Catalog Number
PMC-225
Brand Name
Premom Ovulation Test Cassette (25 test kit)
Version/Model Number
PM2-C
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
CEP
Product Code Name
Radioimmunoassay, Luteinizing Hormone
Public Device Record Key
cc93d191-9473-4da7-8df0-9942dcb0de7b
Public Version Date
February 21, 2019
Public Version Number
2
DI Record Publish Date
July 01, 2018
Package DI Number
10855944007175
Quantity per Package
72
Contains DI Package
00855944007178
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 |