Duns Number:045361136
Device Description: For Use as Linearity Standards in Quantitative Procedures for Acetaminophen, Salicylate, For Use as Linearity Standards in Quantitative Procedures for Acetaminophen, Salicylate, Theophylline, and ß-Hydroxybutyrate.
Catalog Number
2450-604
Brand Name
TDM/B-Hydroxybutyrate Linearity Standards
Version/Model Number
2450-604
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
DKB
Product Code Name
Calibrators, Drug Mixture
Public Device Record Key
a7ecbe3d-540e-4104-ae11-fac7153ee4f9
Public Version Date
April 16, 2018
Public Version Number
3
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 | 69 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |