Duns Number:045623154
Device Description: Pointe Lp(a) Reagent packaged for use on the Mindray BA800. 2 x 60ml R1, 2 x 20ml R2. T Pointe Lp(a) Reagent packaged for use on the Mindray BA800. 2 x 60ml R1, 2 x 20ml R2. The Lp(a) reagent set is an in vitro diagnostic test for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma samples. The measurement of Lp(a) is useful in assessing lipid metabolism disorders and atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.
Catalog Number
16-L7597-160
Brand Name
Pointe Lp(a) Reagent
Version/Model Number
16-L7597-160
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
-
Product Code
DFC
Product Code Name
Lipoprotein, Low-Density, Antigen, Antiserum, Control
Public Device Record Key
c1aed7ce-0904-4fea-99cd-1a5bf4395c3d
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 |