Catalog Number

00-011085

Brand Name

ELVIS

Version/Model Number

00-011085

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

K091753,K941924

Product Code

GQL

Product Code Name

Antisera, fluorescent, herpesvirus hominis 1,2

Public Device Record Key

15a6a346-6436-43eb-a149-2994f02b1cc0

Public Version Date

March 15, 2019

Public Version Number

1

DI Record Publish Date

March 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-