Catalog Number

GSD10-1024

Brand Name

Gold Standard Diagnostics Borrelia burgodorferi IgG/IgM ELISA Test Kit

Version/Model Number

GSD10-1024

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

June 30, 2023

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

-

Product Code

LSR

Product Code Name

Reagent, Borrelia Serological Reagent

Public Device Record Key

693544c1-992a-47ca-a722-83c34c65f69e

Public Version Date

October 17, 2022

Public Version Number

4

DI Record Publish Date

May 21, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-