Catalog Number

5092

Brand Name

Light Diagnostics hMPV Control Slide

Version/Model Number

5092

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

Yes

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

bbf565ad-4b0e-4637-86a5-30803f738b1a

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

-