Duns Number:010717890
Device Description: The Lipoprint System LDL Subfractions Kit is a device intended to measure lipoprotein chol The Lipoprint System LDL Subfractions Kit is a device intended to measure lipoprotein cholesterol (for lipoprotein fractions and subfractions from VLDL to HDL) in fasting serum or plasma with a Total Cholesterol concentration of >100mg/dL. Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment, and clinical evaluation.
Catalog Number
48-7002
Brand Name
Lipoprint LDL Subfractions Kit 4x25 tests
Version/Model Number
48-7002
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"
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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
K010337,K013662
Product Code
JHO
Product Code Name
Electrophoretic Separation, Lipoproteins
Public Device Record Key
907035e6-b24e-4670-afae-c11dd17003a7
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 |