Catalog Number

40-8696M

Brand Name

MarDx

Version/Model Number

40-8696M

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K894293

Product Code

LSR

Product Code Name

Reagent, Borrelia Serological Reagent

Public Device Record Key

b46455f9-89b8-4284-a02e-97a5d67a4be4

Public Version Date

November 06, 2019

Public Version Number

4

DI Record Publish Date

May 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-