Duns Number:045623154
Device Description: Cholesterol Reagent, for the quantitative determination of Total Cholesterol in serum. Siz Cholesterol Reagent, for the quantitative determination of Total Cholesterol in serum. Size: 1 x 2L
Catalog Number
HC710-2000
Brand Name
Pointe Scientific, Inc. Cholesterol
Version/Model Number
HC710-2000
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
-
Product Code
CHH
Product Code Name
Enzymatic Esterase--Oxidase, Cholesterol
Public Device Record Key
4bc28f6b-7741-4dfd-a9fe-2e09bc7d67c5
Public Version Date
March 29, 2018
Public Version Number
2
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 |