Duns Number:080890141
Device Description: Triage TOX Drug Screen, 94600 Control 2
Catalog Number
94614
Brand Name
Triage
Version/Model Number
94614
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DIF
Product Code Name
Drug mixture control materials
Public Device Record Key
2f3af9dc-9f9f-4d7b-b2cd-da9f4fb00c72
Public Version Date
August 01, 2019
Public Version Number
1
DI Record Publish Date
July 24, 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 | 20 |
2 | A medical device with a moderate to high risk that requires special controls. | 20 |