Catalog Number

-

Brand Name

C6 B. burgdorferi (Lyme) ELISA

Version/Model Number

DK-E352-096

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

LSR

Product Code Name

Reagent, Borrelia Serological Reagent

Public Device Record Key

d422e6b9-ceec-436b-9ecc-57ef3e3b8f95

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 15, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-