Catalog Number

CBG-3320

Brand Name

Coxsackie B1-B6 IgG Control

Version/Model Number

CBG-3320

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 30, 2017

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GNN

Product Code Name

Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6

Public Device Record Key

272b4c3e-19ef-411d-8823-e40d1c3bb8f4

Public Version Date

December 21, 2020

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-