Duns Number:045361136
Device Description: For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol in Human For the Quantitative Determination of High Density Lipoprotein (HDL) Cholesterol in Human Serum.
Catalog Number
S0590-540
Brand Name
Sirrus® Direct HDL Cholesterol LiquiColor®
Version/Model Number
S0590-540
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
41a1aa62-80f5-4780-8a98-328aadd4658d
Public Version Date
April 16, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
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 | 69 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |