Duns Number:164880598
Device Description: The ARK™ HS Benzodiazepine II Assay is intended for the qualitative and/or semiquantitati The ARK™ HS Benzodiazepine II Assay is intended for the qualitative and/or semiquantitative determination of benzodiazepines in human urine at cutoff concentrations of 100 ng/mL and 200 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting benzodiazepines in urine and is designated for professional use on automated clinical chemistry analyzers.
Catalog Number
5073-0001-02
Brand Name
ARK™ HS Benzodiazepine II Assay
Version/Model Number
5073-0001-02
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
JXM
Product Code Name
Enzyme Immunoassay, Benzodiazepine
Public Device Record Key
ccc5aba8-d733-4082-93ec-7946216831da
Public Version Date
September 08, 2021
Public Version Number
1
DI Record Publish Date
August 31, 2021
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 |