Duns Number:606814960
Device Description: ISE Low/High Urine Standard for Olympus AU Series Chemistry Systems
Catalog Number
-
Brand Name
PHOENIX DIAGNOSTICS, INC.
Version/Model Number
21-106
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
5f242a53-fa7b-46d0-863d-012ad5a48d88
Public Version Date
March 30, 2020
Public Version Number
3
DI Record Publish Date
January 25, 2018
Package DI Number
10853366007063
Quantity per Package
4
Contains DI Package
00853366007066
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 16 |
2 | A medical device with a moderate to high risk that requires special controls. | 37 |