Duns Number:806777541
Device Description: DOA 12 in 1 Test Cup, 25Pcs/Box without Box Label on Each Box; 12Boxes/Case; First Sign fo DOA 12 in 1 Test Cup, 25Pcs/Box without Box Label on Each Box; 12Boxes/Case; First Sign for Hemosure; CLIA WaivedAMP/BARB/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/PCP/TCA/THC
Catalog Number
FSCCUP-14124-B300
Brand Name
FIRST SIGN®
Version/Model Number
FSCCUP-14124-B300
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
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
682e6fff-9d42-4300-bcf1-ae1d77921c55
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
July 10, 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 |