Catalog Number

GSD01-1025

Brand Name

Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit

Version/Model Number

GSD01-1025

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

K200025,K203296

Product Code

LSR

Product Code Name

Reagent, Borrelia Serological Reagent

Public Device Record Key

eef19ec9-3f98-4f6a-a037-5476fa9288d3

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 24, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-