Duns Number:075886031
Device Description: Validate TDM1ri is intended for the quantitative determination of Calibration Verification Validate TDM1ri is intended for the quantitative determination of Calibration Verification/Linearity of drug analytes on automated instruments.
Catalog Number
301ri
Brand Name
Validate
Version/Model Number
301ri
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
K033879
Product Code
DKB
Product Code Name
Calibrators, Drug Mixture
Public Device Record Key
78b8d290-a1a1-42e2-87fd-e4b12516f4d2
Public Version Date
February 24, 2022
Public Version Number
4
DI Record Publish Date
September 23, 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 | 184 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |