Catalog Number

5092-5

Brand Name

Light Diagnostics Human Metapneumovirus (hMPV) Control Slides (5 pack)

Version/Model Number

5092-5

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

K093815

Product Code

OMG

Product Code Name

Antisera, Fluorescent, Human Metapneumovirus

Public Device Record Key

1c50c65b-1208-4b02-a5a1-0b2bf1f473c4

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

-