Duns Number:014210494
Device Description: HDL-Cholesterol Reagent 1 X 60 mL + 1 X 20 mL
Catalog Number
IR056-X
Brand Name
Synermed®
Version/Model Number
IR056-X
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K072395
Product Code
LBS
Product Code Name
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Public Device Record Key
b41c1a43-a2fa-47ff-8f54-41361963b742
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 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 | 71 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 130 |