Catalog Number

STP/25

Brand Name

EZTest Biological Test Pack

Version/Model Number

10e5

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K001444,K001444

Product Code

FRC

Product Code Name

Indicator, Biological Sterilization Process

Public Device Record Key

864b2c48-268f-422e-ae49-9ac2a6051261

Public Version Date

December 07, 2018

Public Version Number

3

DI Record Publish Date

October 20, 2017

Package DI Number

M985STP251

Quantity per Package

25

Contains DI Package

M985STP250

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case