Duns Number:070371210
Device Description: Reagent for the direct quantitative determination of low density lipoprotein cholesterol ( Reagent for the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma using the Mindray BS-480 analyzer. For in vitro diagnostic use only.4 x 60 ml, 4 x 20 ml
Catalog Number
LDL480
Brand Name
MedTest Dx, Inc. autoLDL Cholestrol
Version/Model Number
LDL480
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)
Yes
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
K981978
Product Code
MRR
Product Code Name
System, Test, Low Density, Lipoprotein
Public Device Record Key
eadc45f2-9ae8-4d02-a8c6-5a47efeb843b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 27, 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 | 38 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 33 |