Duns Number:196929947
Device Description: The CHEMCARD™ Cholesterol Test provides a preliminarysemi-quantitative analytical test res The CHEMCARD™ Cholesterol Test provides a preliminarysemi-quantitative analytical test result that can be used to identify elevated blood cholesterollevels associated with increased risk of coronary artery disease.510K Cleared for Professional Use Only.
Catalog Number
-
Brand Name
Chemcard Cholesterol
Version/Model Number
43001
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K864159,K864159,K864159
Product Code
CHH
Product Code Name
Enzymatic Esterase--Oxidase, Cholesterol
Public Device Record Key
b4b86a7b-00d8-42ef-9c85-2deee67e0390
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 29, 2016
Package DI Number
00737051548327
Quantity per Package
12
Contains DI Package
00737051548310
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |