Catalog Number

-

Brand Name

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)

Version/Model Number

DY 2133-3001-1 M

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K172722

Product Code

LSR

Product Code Name

Reagent, Borrelia Serological Reagent

Public Device Record Key

f8cf0fdc-31d0-4b83-9811-582654071f50

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-