Duns Number:164880598
Device Description: The ARK™ Ethyl Glucuronide Assay is intended for the qualitative and semiquantitative det The ARK™ Ethyl Glucuronide Assay is intended for the qualitative and semiquantitative determination of ethyl glucuronide in human urine at cutoff concentrations of 500 ng/mL and 1000 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting ethyl glucuronide in urine and is designated for professional use on automated clinical chemistry analyzers.
Catalog Number
5036-0004-00
Brand Name
ARK™ Ethyl Glucuronide Assay
Version/Model Number
5036-0004-00
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
-
Product Code Name
-
Public Device Record Key
89d3f998-0f0b-4e80-9327-f2c213228bbe
Public Version Date
August 13, 2018
Public Version Number
1
DI Record Publish Date
July 12, 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 |