Catalog Number

-

Brand Name

Poly Rb A-Hu IgA, IgG, IgM, Kappa, Lambda/FITC

Version/Model Number

F0200

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

CZN

Product Code Name

Iga, Fitc, Antigen, Antiserum, Control

Public Device Record Key

076776e9-6628-4c47-8d3a-a7c078d5e0bb

Public Version Date

December 07, 2020

Public Version Number

6

DI Record Publish Date

January 05, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-