Catalog Number

-

Brand Name

PHOENIX DIAGNOSTICS, INC.

Version/Model Number

13-002

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

Yes

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

9f2427bb-ced5-4ea3-b329-90a91d097453

Public Version Date

March 30, 2020

Public Version Number

3

DI Record Publish Date

January 25, 2018

Package DI Number

10853366007728

Quantity per Package

30

Contains DI Package

00853366007721

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-