Duns Number:806777541
Device Description: DOA Single Test Dip card, 25Pcs/Box; First Sign for Hemosure; CLIA WaivedTHC
Catalog Number
FSCDIPTH-25
Brand Name
FIRST SIGN®
Version/Model Number
FSCDIPTH-25
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DKE
Product Code Name
Reagents, Test, Tetrahydrocannabinol
Public Device Record Key
14dada46-9320-42b0-899b-7b7c2a84bbe0
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
October 07, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |