Duns Number:164880598
Device Description: ARK™ Ethyl Glucuronide 1000 Cutoff Calibrator is intended for use in calibration of the AR ARK™ Ethyl Glucuronide 1000 Cutoff Calibrator is intended for use in calibration of the ARK Ethyl Glucuronide Assay.
Catalog Number
5036-0002-03
Brand Name
ARK™ Ethyl Glucuronide 1000 Cutoff Calibrator
Version/Model Number
5036-0002-03
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
25a003e9-2f37-418a-8cbd-83c30c5237ec
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 29, 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 |