Duns Number:328712260
Device Description: Urine Calibration Standard Metanephrines
Catalog Number
2009
Brand Name
Urine Calibration Standard
Version/Model Number
2009
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
JIX
Product Code Name
Calibrator, Multi-Analyte Mixture
Public Device Record Key
2dc1560e-9acb-4ab2-a269-d3665107db8a
Public Version Date
April 09, 2019
Public Version Number
2
DI Record Publish Date
March 22, 2019
Package DI Number
04250317502933
Quantity per Package
5
Contains DI Package
04250317543370
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 |