Catalog Number

M114

Brand Name

Lyra

Version/Model Number

Parainfluenza Virus Assay

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141927

Product Code

OOU

Product Code Name

Parainfluenza multiplex nucleic acid assay

Public Device Record Key

6320a258-cb8f-42d2-ad31-67db0f00d8e1

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-