Catalog Number

GSD01-1019

Brand Name

Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit

Version/Model Number

GSD01-1019

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 30, 2018

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

20937b1c-0573-440e-8aee-45a6b164741b

Public Version Date

June 04, 2021

Public Version Number

5

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-