Phoenix Diagnostics - ISE Low Serum Standard for Olympus AU Series - PHOENIX DIAGNOSTICS, INC.

Duns Number:606814960

Device Description: ISE Low Serum Standard for Olympus AU Series Chemistry Systems

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More Product Details

Catalog Number

-

Brand Name

Phoenix Diagnostics

Version/Model Number

21-104

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

JIX

Product Code Name

Calibrator, Multi-Analyte Mixture

Device Record Status

Public Device Record Key

aad1f6d5-3d14-467b-85a6-fdb523f40118

Public Version Date

March 30, 2020

Public Version Number

4

DI Record Publish Date

August 12, 2017

Additional Identifiers

Package DI Number

10853366007049

Quantity per Package

4

Contains DI Package

00853366007042

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"PHOENIX DIAGNOSTICS, INC." Characteristics
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