Catalog Number

A1030/6

Brand Name

Idylla™ Respiratory (IFV-RSV) Panel

Version/Model Number

1.0

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

K163628,K163628

Product Code

OCC

Product Code Name

Respiratory Virus Panel Nucleic Acid Assay System

Public Device Record Key

8e599c39-0e75-4adb-8dfb-38bf47bc727a

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

October 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-