Duns Number:545868502
Device Description: This product is intended for the qualitative determination of human chorionic gonadotropin This product is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 3 strips and 3 midstreams in one box.
Catalog Number
-
Brand Name
DAVID
Version/Model Number
82269
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
dc53e7b3-0623-437f-a592-c402f64a3d5e
Public Version Date
October 19, 2020
Public Version Number
2
DI Record Publish Date
August 04, 2020
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 |