Duns Number:227530649
Device Description: Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cholesterol i Enzymatic Clearance assay for the in vitro quantitative determination of HDL-cholesterol in human serum and plasma.
Catalog Number
-
Brand Name
DIRECT HDL-CHOLESTEROL (HDL)
Version/Model Number
CH1383
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
-
Product Code
LBS
Product Code Name
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Public Device Record Key
049fe7b1-7c40-45f3-8901-b94c4d42e943
Public Version Date
October 12, 2022
Public Version Number
1
DI Record Publish Date
October 04, 2022
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 |