Catalog Number

NC-880096-AM

Brand Name

ASI EB VCA IgM EIA Test

Version/Model Number

NC-880096-AM

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

K033780

Product Code

LJN

Product Code Name

Antibody Igm, If, Epstein-Barr Virus

Public Device Record Key

7fc3c5a1-f274-43fc-8006-f1a68f7ea4e9

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

July 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-