Catalog Number

5094

Brand Name

Light Diagnostics VZV DFA Reagent

Version/Model Number

5094

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

K951799

Product Code

GQX

Product Code Name

Antiserum, Cf, Varicella-Zoster

Public Device Record Key

2c4b1bb1-9718-437b-9219-a8f784929c68

Public Version Date

April 13, 2020

Public Version Number

1

DI Record Publish Date

April 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-