Duns Number:806777541
Device Description: First Sign hCG Pregnancy Urine Test Strip (4mm); 25Pcs/Box for Hemosure
Catalog Number
F1-D04
Brand Name
First Sign®
Version/Model Number
F1-ST25
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JHI
Product Code Name
Visual, Pregnancy Hcg, Prescription Use
Public Device Record Key
f76deeec-cfe2-438e-8972-bb153969bb16
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 08, 2017
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |