Catalog Number

I-EBV01X

Brand Name

EBV VCA IgG 10 wl; 10 pk

Version/Model Number

I-EBV01X

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K900974

Product Code

JRY

Product Code Name

Antiserum, Fluorescent, Epstein-Barr Virus

Public Device Record Key

83f8c3c0-6508-4a7f-b40a-1c0b7de08567

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-