Catalog Number

GSD01-3000

Brand Name

GSD Toxocara canis IgG ELISA

Version/Model Number

GSD01-3000

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

MDJ

Product Code Name

Reagents, Cysticercosis

Public Device Record Key

a955a0b7-8a79-4847-8815-c2b09ec39cb6

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

-