Duns Number:227530649
Device Description: The Randox Multidrug Control Level 1 is intended for use in the Quality Control of Methamp The Randox Multidrug Control Level 1 is intended for use in the Quality Control of Methamphetamine, Barbiturates, Cocaine, Methadone and Opiates assays.
Catalog Number
DA3121
Brand Name
DOA CONTROL 1
Version/Model Number
DA3121
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
K113751,K092266,K092268,K092272,K092274,K113747
Product Code
DIF
Product Code Name
Drug Mixture Control Materials
Public Device Record Key
d3febb13-225a-4f30-bbdc-ed608f481d37
Public Version Date
December 21, 2020
Public Version Number
3
DI Record Publish Date
September 24, 2016
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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |