Duns Number:164880598
Device Description: The ARK™ Fentanyl Assay is a homogeneous enzyme immunoassay intended for the qualitative The ARK™ Fentanyl Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative and determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting fentanyl in urine on automated clinical chemistry analyzers.
Catalog Number
5031-0001-01
Brand Name
ARK™ Fentanyl Assay
Version/Model Number
5031-0001-01
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
DJG
Product Code Name
Enzyme Immunoassay, Opiates
Public Device Record Key
ce8caef3-542a-45f1-92c5-974384de7697
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 30, 2017
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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |
| U | Unclassified | 4 |