Catalog Number

55-2408DF

Brand Name

ELVIS

Version/Model Number

55-2408DF

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GQL

Product Code Name

Antisera, fluorescent, herpesvirus hominis 1,2

Public Device Record Key

9b6fdeac-7618-4ab0-9eb3-7cf050b4b95a

Public Version Date

September 07, 2018

Public Version Number

1

DI Record Publish Date

August 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-