Catalog Number

GSD01-3007

Brand Name

GSD Brucella IgG ELISA

Version/Model Number

GSD01-3007

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

-

Product Code

GSM

Product Code Name

Antisera, Fluorescent, Brucella Spp.

Public Device Record Key

93ac92b5-270c-41a0-9bbb-5e62a96667fa

Public Version Date

June 04, 2021

Public Version Number

3

DI Record Publish Date

July 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-