Catalog Number

-

Brand Name

NA

Version/Model Number

K610611-2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 25, 2020

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

-

Product Code

GQN

Product Code Name

Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2

Public Device Record Key

e944d7a7-1390-419d-b22a-1a4374071037

Public Version Date

February 26, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-