Duns Number:227530649
Device Description: Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calib Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibration of the Randox Drugs of Abuse Panel on the Evidence® analyser.
Catalog Number
EV3550
Brand Name
DOA CAL
Version/Model Number
EV3550
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
K030360,K040350,K040570,K041142,K041143,K041144,K043071,K050179
Product Code
DKB
Product Code Name
Calibrators, Drug Mixture
Public Device Record Key
f7e46e86-0913-4409-beea-f68a3d8d8fb7
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 |