Catalog Number

-

Brand Name

Detector H. pylori

Version/Model Number

IHP-30

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"

-

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

LYR

Product Code Name

Helicobacter pylori

Public Device Record Key

c077652d-d8af-4825-ae0d-74179454fe73

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Package DI Number

20722355002020

Quantity per Package

4

Contains DI Package

10722355002023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case of 4