Catalog Number

GSD04-1023

Brand Name

Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - Bulk

Version/Model Number

GSD04-1023

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 11, 2021

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

fe2bed3c-02b8-444e-94eb-6d1bc12ad85e

Public Version Date

August 12, 2021

Public Version Number

5

DI Record Publish Date

July 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-