Duns Number:015875273
Device Description: DrugCheck Single Dip Cassette Drug Test, THC20
Catalog Number
30142C
Brand Name
DrugCheck
Version/Model Number
30142C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
0e335379-8c66-4cba-bbd8-d60653d577d5
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
January 10, 2022
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 286 |
U | Unclassified | 2 |