Catalog Number

401600

Brand Name

NeuMoDx™ Viral Lysis Buffer

Version/Model Number

401600

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PPM

Product Code Name

General Purpose Reagent

Public Device Record Key

1a275d13-70e1-4812-8ad7-56cb5d69ef4b

Public Version Date

December 06, 2021

Public Version Number

2

DI Record Publish Date

March 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-