Catalog Number

5026-2ML

Brand Name

Light Diagnostics Mouse Anti-CMV Monoclonal Antibody

Version/Model Number

5026-2ML

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

K935809

Product Code

GQH

Product Code Name

Antigen, Cf (Including Cf Control), Cytomegalovirus

Public Device Record Key

1d90fec5-70ea-4e4a-81fd-31e9bd2c07cd

Public Version Date

April 27, 2020

Public Version Number

1

DI Record Publish Date

April 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-