Duns Number:354553091
Device Description: The Mercodia Oxidized LDL ELISA kit is intended to be used for the in vitro quantitative m The Mercodia Oxidized LDL ELISA kit is intended to be used for the in vitro quantitative measurement of oxidized low density lipoproteins (oxidized LDL) in human serum or plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Catalog Number
10-1143-01
Brand Name
Mercodia Oxidized LDL ELISA
Version/Model Number
10-1143-01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
February 28, 2023
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MRR
Product Code Name
System, Test, Low Density, Lipoprotein
Public Device Record Key
54b8e052-4630-4ebd-9926-a0bb5ea197a6
Public Version Date
September 02, 2021
Public Version Number
2
DI Record Publish Date
April 08, 2020
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 | 13 |