Duns Number:045623154
Device Description: Reagent for the quantitative determination high-density lipoprotein cholesterol in human s Reagent for the quantitative determination high-density lipoprotein cholesterol in human serum or plasma. For in vitro diagnostic use only.1 x 60ml, 1 x 20ml
Catalog Number
H7545-80
Brand Name
Pointe Scientific, Inc.
Version/Model Number
H7545-80
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
8d5b507a-edc4-4df8-a67d-6a297815f48b
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 |