Duns Number:067647321
Device Description: The EZ-hCGTM Urine test is a one-step immunoassay for the rapid, qualitative determination The EZ-hCGTM Urine test is a one-step immunoassay for the rapid, qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy.
Catalog Number
-
Brand Name
EZ-hCG Urine Pregnancy Test
Version/Model Number
1048-25
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 01, 2020
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K003856
Product Code
JHI
Product Code Name
Visual, Pregnancy Hcg, Prescription Use
Public Device Record Key
1b8b2d95-04f1-42e5-9717-1897eb369706
Public Version Date
September 02, 2021
Public Version Number
4
DI Record Publish Date
December 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |