Duns Number:036225773
Device Description: Origin Instant Oral Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-OPI-OXY-THC
Catalog Number
81025-OD-EI
Brand Name
Origin Instant Oral Drug Test
Version/Model Number
81025-OD-EI
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
PUX
Product Code Name
Test, Amphetamine, Employment And Insurance Testing, Exempt
Public Device Record Key
70947f7f-4beb-4efc-b706-6887c4ccaa84
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
January 24, 2020
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. | 18 |