Duns Number:328712260
Device Description: HPLC Reagent Kit for automated sample preparation, Vitamin C in plasma/serum
Catalog Number
65765/F
Brand Name
Reagent Kit
Version/Model Number
65765/F
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 08, 2022
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JMA
Product Code Name
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
Public Device Record Key
8be8e2d2-ffec-4394-b630-c66ddb3570ff
Public Version Date
July 11, 2022
Public Version Number
2
DI Record Publish Date
August 27, 2020
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 | 455 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |