Catalog Number

40-8696G

Brand Name

MarDx

Version/Model Number

40-8696G

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

K894224

Product Code

LSR

Product Code Name

Reagent, Borrelia Serological Reagent

Public Device Record Key

b6e6db83-bdd7-431a-a73b-26b60aef2d3b

Public Version Date

November 04, 2019

Public Version Number

1

DI Record Publish Date

October 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-