Duns Number:164880598
Device Description: ARK™Pregabalin II Control is intended for use in quality control of the ARK™Pregabalin II ARK™Pregabalin II Control is intended for use in quality control of the ARK™Pregabalin II Assay.
Catalog Number
5059-0003-00
Brand Name
ARK™ Pregabalin II Control
Version/Model Number
5059-0003-00
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
LAS
Product Code Name
Drug Specific Control Materials
Public Device Record Key
cf280542-fbd5-4d97-afac-508979e9de5a
Public Version Date
July 11, 2019
Public Version Number
1
DI Record Publish Date
July 03, 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 |