Duns Number:164880598
Device Description: The ARK™ Fentanyl II Assay is a homogeneous enzyme immunoassay intended for the qualitati The ARK™ Fentanyl II Assay is a homogeneous enzyme immunoassay intended for the qualitative determination of fentanyl in human urine at a cutoff concentration of 0.5 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting fentanyl in urine on automated clinical chemistry analyzers.
Catalog Number
5072-0001-00
Brand Name
ARK™ Fentanyl II Assay - 500mL (WPT)
Version/Model Number
5072-0001-00
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
cfa5a1b3-449f-4aab-a629-13fd33735c70
Public Version Date
July 16, 2020
Public Version Number
1
DI Record Publish Date
July 08, 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 |
|---|---|---|
| 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 |