MarDx - Borrelia burgdorferi EIA IgM - CLARK LABORATORIES, INC.

Duns Number:623214079

Device Description: Borrelia burgdorferi EIA IgM

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More Product Details

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

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K894293

Product Code Details

Product Code

LSR

Product Code Name

Reagent, Borrelia Serological Reagent

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CLARK LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 50
2 A medical device with a moderate to high risk that requires special controls. 116