Catalog Number

3-701

Brand Name

PHOENIX DIAGNOSTICS, INC.

Version/Model Number

3-701

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

b5d9765c-3ac9-4f9d-8d70-02457f51ec90

Public Version Date

November 18, 2020

Public Version Number

4

DI Record Publish Date

February 15, 2018

Package DI Number

10852676007756

Quantity per Package

4

Contains DI Package

00852676007759

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-