Duns Number:328712260
Device Description: Internal Standard Mix, MassChrom® Free Metanephrines in plasma
Catalog Number
81004
Brand Name
Reagent
Version/Model Number
81004
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
CHQ
Product Code Name
Chromatographic/Fluorometric Method, Catecholamines
Public Device Record Key
9a4a5135-b2cc-455b-9415-d5e04cc03090
Public Version Date
September 04, 2020
Public Version Number
1
DI Record Publish Date
August 27, 2020
Package DI Number
04250317536778
Quantity per Package
2
Contains DI Package
04250317546463
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |