Duns Number:065602744
Device Description: Single Panel Pre Screen Plus Dip Card Drug Combo: THC
Catalog Number
-
Brand Name
Single Panel Pre Screen Plus Dip Card
Version/Model Number
PS-THC-114
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LDJ
Product Code Name
Enzyme Immunoassay, Cannabinoids
Public Device Record Key
22dc6522-7847-4dda-9c0d-a0854cfa9c0a
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
July 26, 2016
Package DI Number
10850557007413
Quantity per Package
20
Contains DI Package
00850557007409
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 23 |