Duns Number:045623154
Device Description: Pointe Scientific, Inc. Lipid Control Set are assayed Lipid Controls produced from fresh h Pointe Scientific, Inc. Lipid Control Set are assayed Lipid Controls produced from fresh human sera to monitor the accuracy and precision of quantitative lipid determinations of human sera specimens.6 x 3 ml.
Catalog Number
L7580-18
Brand Name
Pointe Scientfic, Inc. Lipid Controls
Version/Model Number
L7580-18
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
K951749
Product Code
JJY
Product Code Name
Multi-Analyte Controls, All Kinds (Assayed)
Public Device Record Key
676ae66a-241c-495c-b46d-80667161faa5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |