Duns Number:010717890
Device Description: The Liposure Lipoprotein Control is intended for monitoring lipoprotein fractions (VLDL to The Liposure Lipoprotein Control is intended for monitoring lipoprotein fractions (VLDL to HDL) as well as subfractions (Mid-bands, LDL subfractions 1, 2, and 3) using the Lipoprint LDL System to validate the separation and quantitation of lipoproteins in patient serum samples. It is prepared from human serum and supplied lyophilized. The lyophilized material contains stabilizers and preservatives.
Catalog Number
48-7060
Brand Name
Liposure Serum Lipoprotein Control Level 1 4x0.5mL
Version/Model Number
48-7060
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K010337,K013662
Product Code
JHO
Product Code Name
Electrophoretic Separation, Lipoproteins
Public Device Record Key
e40280b0-beae-4f39-b9ac-632530de6cc0
Public Version Date
October 29, 2018
Public Version Number
1
DI Record Publish Date
September 26, 2018
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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |