Duns Number:164880598
Device Description: The ARK™ Meperidine Assay is intended for the qualitative and/or semiquantitative determi The ARK™ Meperidine Assay is intended for the qualitative and/or semiquantitative determination of meperidine in human urine at cutoff concentrations of 100 ng/mL. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only.
Catalog Number
5039-0001-01
Brand Name
ARK™ Meperidine Assay
Version/Model Number
5039-0001-01
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
acf4f504-3670-4a22-a170-7b2e04a29946
Public Version Date
July 30, 2019
Public Version Number
1
DI Record Publish Date
July 22, 2019
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 |