Duns Number:227530649
Device Description: An HDL-cholesterol test system is a device intended for the quantitative in vitro determin An HDL-cholesterol test system is a device intended for the quantitative in vitro determination of HDL-cholesterol concentration in human serum and plasma.
Catalog Number
CH3811
Brand Name
HDL
Version/Model Number
CH3811
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
K982341
Product Code
LBS
Product Code Name
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Public Device Record Key
8271acf4-c007-4533-8206-4b3d140c69aa
Public Version Date
January 24, 2019
Public Version Number
1
DI Record Publish Date
December 24, 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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |