Duns Number:068331990
Device Description: FHC-102H Dollar General Preg One Step Cassette
Catalog Number
-
Brand Name
DG Health One Step Pregnancy Test
Version/Model Number
FHC-102H
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
K012215,K012215
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
f1234d07-e812-41f1-a6da-0aa568982c77
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 30, 2016
Package DI Number
10430000702074
Quantity per Package
96
Contains DI Package
00430000702077
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |
| U | Unclassified | 1 |