Catalog Number

5243

Brand Name

Light Diagnostics SimulFluor HSV 1/HSV 2 Reagent

Version/Model Number

5243

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K991880

Product Code

GQN

Product Code Name

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

Public Device Record Key

001f8385-2ff1-4a52-9baa-b71d1a06c69a

Public Version Date

April 24, 2020

Public Version Number

1

DI Record Publish Date

April 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-