Duns Number:045361136
Device Description: Quantitative-Enzymatic-Colorimetric Determination of Total and HDL Cholesterol in Serum or Quantitative-Enzymatic-Colorimetric Determination of Total and HDL Cholesterol in Serum or Plasma.
Catalog Number
1012-030
Brand Name
Cholesterol Standard (200 mg/dL)
Version/Model Number
1012-030
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CHH
Product Code Name
Enzymatic Esterase--Oxidase, Cholesterol
Public Device Record Key
ef848634-9bbb-48ce-8b22-b45c40e0c9a4
Public Version Date
April 16, 2018
Public Version Number
3
DI Record Publish Date
September 23, 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 | 69 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |