Catalog Number

GIS-62-2ML

Brand Name

Urease

Version/Model Number

GIS-62-2ML

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K012411

Product Code

LYR

Product Code Name

Helicobacter Pylori

Public Device Record Key

201b0a69-12d5-4def-9070-830594f8b6e1

Public Version Date

July 16, 2021

Public Version Number

1

DI Record Publish Date

July 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-