Catalog Number

GSD10-1022

Brand Name

Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit

Version/Model Number

GSD10-1022

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K113847

Product Code

LSR

Product Code Name

Reagent, Borrelia Serological Reagent

Public Device Record Key

ea2f62a9-fb90-42e2-9127-41b0f128fa5c

Public Version Date

June 04, 2021

Public Version Number

3

DI Record Publish Date

April 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-