Duns Number:048144997
Device Description: For the in vitro quantitative determination of Triglycerides in serum or plasma. Triglycer For the in vitro quantitative determination of Triglycerides in serum or plasma. Triglycerides determinations are of interest in the diagnosis and treatment of atherosclerosis, poorly controlled diabetes mellitus, nephrosis, liver disease, or other diseases involving lipid metabolism.
Catalog Number
501-417
Brand Name
Triglycerides Reagent
Version/Model Number
500mL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2019
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CDT
Product Code Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Public Device Record Key
3aecc73b-3d4a-42ab-bbf0-2b421a6ea188
Public Version Date
March 31, 2020
Public Version Number
3
DI Record Publish Date
October 12, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |