Duns Number:045623154
Device Description: Pointe autoHDL Cholesterol Reagent packaged for use on the Mindray BA800. 4 x 60ml R1, 4 x Pointe autoHDL Cholesterol Reagent packaged for use on the Mindray BA800. 4 x 60ml R1, 4 x 20ml R2. For the quantitative determination high-density lipoprotein cholesterol in human serum or plasma using the Mindray BA-800M analyzer. For in vitro diagnostic use only. Rx Only.
Catalog Number
16-H7545-320
Brand Name
Pointe autoHDL Cholesterol Reagent
Version/Model Number
16-H7545-320
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
K992002
Product Code
LBR
Product Code Name
Ldl & Vldl Precipitation, Hdl
Public Device Record Key
485561fd-093d-44eb-866d-db70e0a8c974
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 |