Duns Number:797393659
Device Description: Drug Test Cup 5 for visual qualitative detection of THC, COC, AMP, BZO and OPI300
Catalog Number
DS93S625
Brand Name
Accutest
Version/Model Number
DS93S625
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
K082898,K082898
Product Code
DJG
Product Code Name
Enzyme Immunoassay, Opiates
Public Device Record Key
ae23ced2-ef01-4daf-a3ed-c271105e944b
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
March 05, 2019
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |