Duns Number:126544316
Device Description: In Vitro Diagnostic Test kit for the detection of Tricyclic antidepressant, Opiate, Metham In Vitro Diagnostic Test kit for the detection of Tricyclic antidepressant, Opiate, Methamphetamine, Phencyclidine, MDMA, and Amphetamine in human urine.
Catalog Number
AD603U
Brand Name
Nano-CheckTM DAT 6M
Version/Model Number
AD603U
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
-
Product Code Name
-
Public Device Record Key
1ec6bead-2bd9-4e2b-9668-5607387e4753
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
July 03, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-