Duns Number:328712260
Device Description: MassChrom® Biogenic Amines/Metabolites in urine, Sample Prep Set VMA, HVA, 5-HIAA includin MassChrom® Biogenic Amines/Metabolites in urine, Sample Prep Set VMA, HVA, 5-HIAA including collection plates
Catalog Number
80800/96
Brand Name
Reagent Kit
Version/Model Number
80800/96
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CDF
Product Code Name
Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
Public Device Record Key
16009da0-2921-4052-b2f9-91a66c0049a8
Public Version Date
September 04, 2020
Public Version Number
1
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 |