Duns Number:045623154
Device Description: Pointe autoLDL Cholesterol Reagent packaged for use on the Mindray BA800. 5 x 60ml R1, Pointe autoLDL Cholesterol Reagent packaged for use on the Mindray BA800. 5 x 60ml R1, 5 x 20ml R2. For the direct quantitative determination of low density lipoprotein cholesterol (LDL-C) in human serum or plasma. For in vitro diagnostic use only.
Catalog Number
16-L7574-400
Brand Name
Pointe autoLDL Cholesterol Reagent
Version/Model Number
16-L7574-400
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
K981978
Product Code
MRR
Product Code Name
System, Test, Low Density, Lipoprotein
Public Device Record Key
02a415ad-bcb5-46d9-9e79-153f83d5b94c
Public Version Date
February 08, 2021
Public Version Number
1
DI Record Publish Date
January 30, 2021
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |