Catalog Number

NA-5140

Brand Name

EBNA Positive Control

Version/Model Number

NA-5140

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 08, 2022

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

K894626

Product Code

LLM

Product Code Name

Test, Antigen, Nuclear, Epstein-Barr Virus

Public Device Record Key

5b9a8ca3-16e1-40d4-9985-7c70264c10f4

Public Version Date

March 09, 2022

Public Version Number

5

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-