Duns Number:545868502
Device Description: DAVID Ovulation & Pregnancy Test Kit is consisiting of 40 ovulation test strips, 10 pregna DAVID Ovulation & Pregnancy Test Kit is consisiting of 40 ovulation test strips, 10 pregnancy test strips and 2 pregnancy crystal tests.
Catalog Number
-
Brand Name
DAVID
Version/Model Number
82641
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
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
8a833fc3-a110-4825-8ce4-598d1e9b62f6
Public Version Date
July 25, 2022
Public Version Number
1
DI Record Publish Date
July 15, 2022
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 |