Catalog Number

303278

Brand Name

PRODESSE

Version/Model Number

PROGASTRO SSCS ASSAY

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K123274

Product Code

LLH

Product Code Name

REAGENTS, CLOSTRIDIUM DIFFICILE TOXIN

Public Device Record Key

d834b403-8702-448f-a03f-f2945fc33bbf

Public Version Date

October 15, 2020

Public Version Number

4

DI Record Publish Date

April 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-