Duns Number:690598875
Device Description: The L-Type HDL-C is an in vitro assay for the quantitative determination of high density l The L-Type HDL-C is an in vitro assay for the quantitative determination of high density lipoprotein cholesterol (HDL-C) in serum. (4 each 600 mL)
Catalog Number
997-00201
Brand Name
L-Type HDL-C (Reagent 2)
Version/Model Number
997-00201
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 23, 2020
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
Yes
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
K963847,K963847
Product Code
JIS
Product Code Name
Calibrator, Primary
Public Device Record Key
299f709a-e933-4b4d-b278-9a16b0c1e7da
Public Version Date
March 08, 2022
Public Version Number
6
DI Record Publish Date
November 11, 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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |