Catalog Number

-

Brand Name

Rapicide PA Test Strips

Version/Model Number

ML02-0118

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K152394,K152394,K152394

Product Code

JOJ

Product Code Name

Indicator, Physical/Chemical Sterilization Process

Public Device Record Key

5b2b8c65-c54c-43c5-b932-91298ed7f0c2

Public Version Date

April 27, 2022

Public Version Number

5

DI Record Publish Date

February 26, 2018

Package DI Number

30677964064075

Quantity per Package

2

Contains DI Package

10677964064071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box