Duns Number:545868502
Device Description: The David Ovulation Test (Urine) is a self-testing rapid chromatographic immunoassay for t The David Ovulation Test (Urine) is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. This test strip is used to obtain a visual result. It is intended for non-professional, over-the counter (OTC) use.
Catalog Number
RH-LH-S01
Brand Name
DAVID Ovulation Test (Urine)
Version/Model Number
80043
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 08, 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
-
Product Code
NGE
Product Code Name
Test, Luteinizing Hormone (Lh), Over The Counter
Public Device Record Key
af0523f9-f9ea-4058-89ff-7c38aca46ff7
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
August 08, 2016
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 |