Duns Number:031802328
Device Description: hCG women pregnancy Test midstream (Urine; 25mIU/ml)
Catalog Number
GAHCG-103a
Brand Name
Healgen
Version/Model Number
GAHCG-103a
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
a7069a62-a06f-438c-91c0-32d69c3de9be
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 31, 2016
Package DI Number
20816490021135
Quantity per Package
50
Contains DI Package
10816490021138
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 240 |