NeuMoDx™ Vantage Viral Lysis Buffer - NeuMoDx™ Vantage Viral Lysis Buffer - Neumodx Molecular, Inc.

Duns Number:078667309

Device Description: NeuMoDx™ Vantage Viral Lysis Buffer

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More Product Details

Catalog Number

401500

Brand Name

NeuMoDx™ Vantage Viral Lysis Buffer

Version/Model Number

401500

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

PPM

Product Code Name

General Purpose Reagent

Device Record Status

Public Device Record Key

5db87a1f-3f80-4e87-bd2f-f22f12b75eb6

Public Version Date

December 22, 2021

Public Version Number

1

DI Record Publish Date

December 13, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEUMODX MOLECULAR, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 2