Duns Number:606814960
Device Description: ISE Buffer Solution for Olympus AU Series Chemistry Systems
Catalog Number
-
Brand Name
Phoenix Diagnostics
Version/Model Number
21-101
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
K020148,K020148
Product Code
JIX
Product Code Name
Calibrator, Multi-Analyte Mixture
Public Device Record Key
73d15445-34cc-44e7-8d63-19f83496249c
Public Version Date
September 26, 2019
Public Version Number
4
DI Record Publish Date
August 12, 2017
Package DI Number
10853366007018
Quantity per Package
4
Contains DI Package
00853366007011
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 |