Duns Number:328712260
Device Description: Calibration Standard VMA, HVA, 5-HIAA
Catalog Number
1003/B
Brand Name
Calibration Standard
Version/Model Number
1003/B
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
945858ed-ce54-490d-8143-4d916679f4e3
Public Version Date
April 01, 2019
Public Version Number
1
DI Record Publish Date
March 22, 2019
Package DI Number
04250317500212
Quantity per Package
5
Contains DI Package
04250317543226
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 |