Duns Number:164880598
Device Description: ARK™ Fentanyl Cutoff Calibrator is intended for use in the calibration of the ARK™ Fentany ARK™ Fentanyl Cutoff Calibrator is intended for use in the calibration of the ARK™ Fentanyl Assay.
Catalog Number
5052-0002-02
Brand Name
ARK™ Fentanyl Cutoff Calibrator (WPT)
Version/Model Number
5052-0002-02
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
DLJ
Product Code Name
Calibrators, Drug Specific
Public Device Record Key
e28b6445-2391-462b-82ba-80e45b458021
Public Version Date
May 28, 2018
Public Version Number
1
DI Record Publish Date
April 26, 2018
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 |