Catalog Number

-

Brand Name

Poly Rb A-Hu IgM/FITC

Version/Model Number

F0203

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

DFS

Product Code Name

IGM, FITC, ANTIGEN, ANTISERUM, CONTROL

Public Device Record Key

fe8999ed-402b-41ad-b763-4106ac2d5c32

Public Version Date

December 07, 2020

Public Version Number

7

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-