Catalog Number

GSD01-1023

Brand Name

Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit

Version/Model Number

GSD01-1023

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

K113846

Product Code

LSR

Product Code Name

Reagent, Borrelia Serological Reagent

Public Device Record Key

66b66c89-3c84-487c-83d9-61648f31f140

Public Version Date

June 04, 2021

Public Version Number

2

DI Record Publish Date

July 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-